inforMED
InjuryILZ

OFFSET TRAPEZE BAR

Received Dec 8, 1998 · Event occurred Feb 27, 1997

Report MW4002393 · MDR key 202852

Device

Generic name

Traction Accessory

Manufacturer

Invacare Corp.

Model number

7740

Catalog number

97-32

Lot number

NA

Product problems

  • Collapse
  • Detachment Of Device Component
  • Component Falling

Patient

NO INFO

  • Wound Dehiscence
  • Pain
  • Hernia
  • Discomfort
  • Surgical procedure

Narrative

Description of Event or Problem

INVESTIGATION DETERMINED NO FAILURE OF TRAPEZE, NOR HAD VENDOR RECEIVED SIMILAR COMPLAINTS. ON 1/25/99, FOLLOWED UP ON THE CONSUMER COMPLAINT REGARDING AN ALLEGED INJURY CAUSED BY THE COLLAPSE OF AN INVACARE FIXED (CLAMP ON) TRAPEZE BAR ON COMPLAINANT'S STOMACH NEAR A RECENT SURGICAL INCISION. THE FOLLOWING IS A SUMMARY OF THE DISCUSSION THAT TOOK PLACE: TWO MEN FROM A FIRM DELIVERED AND SET UP BED AND TRAPEZE AT COMPLAINANT'S HOME; INVOICE DATED 2/3/97 DOCUMENTS THE DELIVERY AND SET UP DATE; BED, TRAPEZE AND CLAMPS WERE DELIVERED WITH ALL PARTS EXPOSED TO ENVIRONMENT AND NOT IN THEIR ORIGINAL PACKAGING. THE TWO EMPLOYEES DID NOT TELL THE COMPLAINANT AND HIS WIFE THAT CLAMPS MUST BE CHECKED ON A REGULAR BASIS TO PREVENT FAILURE; EMPLOYEES USED A WRENCH TO TIGHTEN UP THE CLAMPS WING NUTS; TRAPEZE BAR ITSELF IS "L" SHAPED, BUT ITS STEEL TUBING IS SHAPED INTO EITHER AN OCTAGON OR A SQUARE; THE CLAMPS USED WERE NOT IDENTIFIED WITH ANY IDENTIFICATION NUMBER; THE ACTUAL BED, TRAPEZE AND CLAMPS DELIVERED TO COMPLAINANT WERE UNTRACEABLE. FIRM CANNOT IDENTIFY OR RECALL ACTUAL UNIT DELIVERED TO COMPLAINANT); PT IS 6'3" TALL AND WEIGHED 200 LBS AT TIME OF INCIDENT; PT WAS UNSURE IF BAR OR CLAMPS FAILED; BED'S HEADBOARD WAS SET UP 18" FROM BEDROOM WALL; TRAPEZE WAS SET UP IN MIDDLE OF HEADBOARD; THE INJURY OCCURRED ON 2/27/97; FIRM WAS NOTIFIED OF INJURY ON 2/27/97; FIRM EMPLOYEES RETURNED TO COMPLAINANT'S HOME ON 2/27/97 AND TIGHTENED UP CLAMPS WING NUTS; COMPLAINANT CONTINUED TO USE ORIGINAL BED, TRAPEZE BAR AND CLAMPS UNTIL 3/26/97; FIRM EMPLOYEES FAILED TO PROVIDE COMPLAINANT AND HIS WIFE WITH USER/MAINTENANCE INSTRUCTIONS; PT SUBMITTED A VOLUNTARY MDR TO INVACARE; PT ESTIMATED THAT TRAPEZE WEIGHED 20 LBS AND ESTIMATED DISTANCE TRAPEZE FELL AT 4 FEET RESULTING IN 57 POUNDS OF BLUNT FORCE. ON 1/25/99, INVESTIGATOR FOLLOWED UP ON THIS COMPLAINT WITH FIRM. FIRM WAS INSPECTED PREVIOUSLY ON 11/6/89, AND WAS KNOWN BY ANOTHER NAME. INVESTIGATOR SHOWED HIS CREDENTIALS AND ISSUED A NOTICE OF INSPECTION. STAFF MEMBER STATED THAT HE WAS AWARE OF THE COMPLAINT AND PROVIDED SOME BACKGROUND INFO ON THE FIRM. A MGMT EMPLOYEE STATED THAT HIS DRIVERS INSTRUCTED THE PT IN PROPER USE, OPERATION AND CARE OF TRAPEZE AND BED. HOWEVER, ACCORDING TO EMPLOYEE, TWO EMPLOYEES WHO DELIVERED AND SET UP BED AND TRAPEZE DID NOT PROPERLY IDENTIFY DEVICES SET UP. INVESTIGATOR REFERRED TO INVOICE DATED 2/3/97 WHICH SHOWS THAT BED WAS IDENTIFIED BY DIFFERENT NUMBERS. EMPLOYEE STATED THAT THOSE NUMBES WERE NO LONGER IN USE AND HAD BEEN REPLACED BY A NEW SET OF NUMBERS. FOR SOME UNK REASON, THE 3RD PARTY CANNOT TRACE BACK THE ORIGINAL BED AND TRAPEZE BAR DELIVERED AND SET UP AT PT'S RESIDENCE. FURTHERMORE, EMPLOYEE STATED THAT CLAMPS USED TO SECURE TRAPEZE WERE NOT IDENTIFIED IN ANY MANNER AND CANNOT BE TRACED BACK. A FORMER MGR WHO FOLLOWED UP INJURY COMPLAINT, NO LONGER WORKS FOR THIS FIRM. ONE OF EMPLOYEES WHO DELIVERED AND SET UP BED AND TRAPEZE, ALSO NO LONGER WORKS FOR FIRM. INVESTIGATOR DID SPEAK WITH ANOTHER EMPLOYEE, WHO WAS BEING TRAINED AT THE TIME OF DELIVERY AND SET UP AT PT'S RESIDENCE. HE SET UP A SIMILAR BED AND TRAPEZE UNIT FOR INVESTIGATOR. PHOTOGRAPHS WERE TAKEN AT THIS TIME AND WILL BE IDENTIFIED LATER IN THIS MEMORANDUM. MGMT EMPLOYEE STATED THAT FORMER MGR WAS LET GO BECAUSE HE DID NOT FOLLOW PROPER PROCEDURES FOR INVESTIGATING AND NOTIFYING UPPER MGMT OF THIS COMPLAINT, AS WELL AS FOR OTHER PROBLEMS WHICH HE DECLINED TO EXPLAIN IN DETAIL. THE MGMT EMPLOYEE STATED THAT HE FOUND OUT ABOUT THIS INJURY COMPLAINT SOMETIME DURING 11/98, AND TRIED TO DUPLICATE FAILURE. HE STATED THAT WHEN THE TWO EMPLOYEES WENT TO FOLLOW UP ON INJURY COMPLAINT ON 2/27/97, THEY NOTICED THAT BOTTOM CLAMP WAS LYING ON FLOOR, AND THAT TOP CLAMP STILL SECURED TRAPEZE BAR. EMPLOYEES TIGHTENED UP BOTH CLAMPS AND PT CONTINUED TO USE SAME BED, TRAPEZE AND CLAMPS UNTIL 3/26/97. INVESTIGATOR OBSERVED A STAFF MEMBER SET UP A BED, AND TRAPEZE BAR USING CLAMPS SIMILAR TO THAT SET UP FOR PT. STAFF MEMBER TIGHTENED CLAMPS WING NUTS BY USING A PAIR OF PLIERS. INVESTIGATOR HAD HIM REMOVE BOTTOM CLAMP AND OBSERVED THAT TRAPEZE DID NOT COLLAPSE, BUT WAS STILL SECURED TO THE BED'S HEADBOARD. MGMT EMPLOYEE TOLD INVESTIGATOR THAT IF HE PULLED DOWN ON TRAPEZE, TOP CLAMP WOULD BREAK BEFORE IT WOULD FALL ON PT. SINCE TOP CLAMP HAD NOT BROKEN DURING THIS COMPLAINT (INCLUDING BOTTOM CLAMP), HE ASSUMED THAT PT HAD FILED A FALSE CLAIM FOR DAMAGES. INITIALLY, PT SOUGHT IN EXCESS OF $300,000 IN DAMAGES. HOWEVER, FIRM SETTLED OUT OF COURT WITH PT FOR MEDICAL EXPENSES AND LAWYER FEES. THE MGMT EMPLOYEE STATED THAT HE HAS BEEN IN HOME HEALTH INDUSTRY FOR OVER SIXTEEN YEARS, AND HE HAS NEVER HEARD OF THIS TYPE OF INJURY COMPLAINT REGARDING LOSS OF LOWER CLAMP LEADING TO COLLAPSE OF TRAPEZE. HE DID SAY THAT HE HEARD OF TOP CLAMP COMING OFF TRAPEZE DUE TO A FAILED ALUMINUM WING NUT. THIS WOULD HAVE RESULTED IN COLLAPSE OF TRAPEZE AND WOULD BE EVIDENCED BY A BROKEN CLAMP. HOWEVER, CLAMPS USED FOR PT'S BED WERE UNDAMAGED AND BED/TRAPEZE CONTINUED TO BE USED FOR ALMOST A MONTH AFTER INJURY WAS REPORTED TO FIRM. HE ESTIMATED LIFE OF TIP AND BOTTOM CLAMPS AT ABOUT TEN YEARS. IN FACT, HE STATED THAT FIRM CONTINUES TO LEASE BEDS TO PTS THAT ARE FOUR YEARS OLD. HE STATED THAT SINCE LAST YEAR, FIRM IS MAINLY INVOLVED IN DELIVERY OF MEDICAL OXYGEN. HOWEVER, IN CONJUNCTION WITH OXYGEN DELIVERY, FIRM MAY DELIVER AN AND SET UP ON AVERAGE TWO BED AND TAPEZE UNITS MONTHLY. HE ESTIMATED RETAIL COST OF BED AT $1,800.00 AND OF TRAPEZE AT $300.00. BED IS LEASED FOR $150.00 AND THE TRAPEZE FOR $30.00 PER MONTH. HE STATED THAT INVACARE TRAPEZE WILL ALSO FIT ON A SMITH & DAVIES BED HEADBOARD. INVESTIGATOR REQUESTED A COPY OF SPECS SHEET FOR TOP AND BOTTOM CLAMPS FOR THIS TRAPEZE UNIT. SPECIFICALLY, INVESTIGATOR WANTED TO KNOW SPECS FOR SCREWS USED ON CLAMPS. HE STATED THAT HE WILL OBTAIN THIS FROM INVACARE. CONTINUED IN B7.