inforMED

HILL-ROM VERSACARE PATIENT HELPER ADAPTER

Received Jan 25, 2008 · Event occurred Jan 7, 2008

Report 997626 · MDR key 997626

Device

Generic name

Traction Assist System

Manufacturer

Zimmer , Inc.

Model number

*

Catalog number

00-0965-000-00

Lot number

*

Product problems

  • Component Falling
  • Design/structure problem
  • Unknown (for use when the device problem is not known)
  • Sharp/jagged/rough/etched/scratched

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

HOSPITAL PURCHASED HILL-ROM VERSA CARE BEDS FOR USE ON A NEWLY OPENING TRAUMA SPECIALTY CARE UNIT. WE HAD A NEED FOR TRACTION PATIENT ASSIST BRACKETS FOR THE NEW BEDS. ( HILL-ROM PUBLISHES A DOCUMENT OF TRACTION ACCESSORIES AVAILABLE FROM OTHER VENDORS FOR THE VERSA CARE BED ON THEIR WEBSITE @ HILL-ROM.COM ) WE PURCHASED THE ZIMMER PATIENT HELPER BRACKET/BAR ASSEMBLY ONLY TO FIND OUT ONCE THEY WERE INSTALLED ON THE BEDS THAT THERE IS AN INHERENT SAFETY PROBLEM WITH THE BRACKET SET UP. THIS HELPER BAR SLIDES INTO A TUBE ATTACHED TO THE HEAD OF THE BED AND IS SECURED BY A HAND KNOB AT AN ADJUSTMENT CLAMP, ALLOWING YOU TO VARY THE HEIGHT OF THE BAR ASSEMBLY ABOVE THE PATIENT. IF YOU ATTEMPT TO ADJUST THE BAR BY LOOSENING THE HAND CLAMP, AND YOU ARE NOT HOLDING ONTO THE BAR, IT WILL SLAM DOWN TOWARDS THE PATIENT'S HEAD. THERE IS A POTENTIAL FOR SERIOUS INJURY. THE OTHER PROBLEM IDENTIFIED; AS THE BAR SLAMS DOWN, THE METAL ON THE BAR GETS SHAVED, IF YOU WILL , TO A POINT OF HAVING VERY SHARP BURRS LEFT ON THE BAR. THOSE BURRS COULD CAUSE CUTS TO CAREGIVERS HANDS OR ANYONE WHO TRIES TO GET THE BAR OFF THE BED.====================== MANUFACTURER RESPONSE FOR TRACTION PATIENT ASSIST BAR, HILL-ROM VERSACARE PATIENT HELPER ADAPTER======================INITIALLY THEY INDICATED THERE WAS NO TYPE OF SAFTEY LOCK OR STOP AVAILABLE AND THAT WHEN WE ADJUSTED THE BAR WE HAD TO HOLD ON TO IT. TODAY WE HAD A REP FROM ZIMMER COME IN TO SEE OUR CONCERN FIRST HAND, WE GAVE HIM A LITTLE DEMO OF THE SLAMING DOWN OF THE BAR ON AN EMPTY BED, AND SHOWED HIM THE SHAVED METAL BURRS ON THE BAR AFTERWARDS.