inforMED
MalfunctionCBF

UNK

Received Aug 21, 1998

Report MW1014459 · MDR key 183775

Device

Generic name

Hyperbaric Chamber

Model number

3200

Catalog number

NI

Lot number

NI

Product problems

  • Dislodged
  • Loose
  • Material Separation

Patient

NA

Narrative

Description of Event or Problem

RPTR WRITES, "THIS LETTER IS TO FOLLOW UP ON OUR PREVIOUS CONVERSATIONS REGARDING BED RAIL BRACKET LOOSENING IN SECHRIST MODEL 3200 HYPERBARIC CHAMBERS. TO DATE, I HAVE OBSERVED RAIL BRACKET LOOSENING OCCURRING IN SIX CHAMBERS, FIVE OWNED BY US AND ONE LOCATED AT " ANOTHER FACILITY. SERIAL NUMBERS AND LOCATIONS OF OUR AFFECTED CHAMBERS ARE "ALL UNITS HAD BEEN IN SVC FOR LESS THAN ONE YR AT THE TIME OF OCCURRENCE. THE PROBLEM OCCURS FIRST IN THE RIGHT HAND RAIL IN ALL CHAMBERS. THE BOLT WHICH SECURES THE RAIL TO THE CRADLE BACKS OUT FROM THE RECEIVER CUP, FREEING THE RAIL. USUALLY THE FIRST INDICATION OF A PROBLEM IS THE RECEIVER CUP COMING OUT OF THE RAIL END WHEN THE GURNEY IS UNMATED FROM THE CHAMBER. INSTABILITY OF THE RAIL THEN RESULTS IN LOOSENING OF THE ENTIRE RAIL CRADLE/BRACKET ASSEMBLY. I BELIEVE THERE ARE TWO FACTORS WHICH CONTRIBUTE TO THIS PROBLEM: 1) THE RAIL RETAINER BOLT IS TOO SHORT [APPEARS TO BE AROUND 3/8"] AND 2) NO LOCK-TITE WAS APPLIED TO THE BOLT [NO RESIDUE NOTED ON THE BOLT OR RECEIVER CUP THREADS. THIS APPEARS TO BE AN ASSEMBLY PROBLEM. IT DOES SEEM UNUSUAL THAT THE PROBLEM INITIALLY OCCURS ON THE RIGHT HAND RAIL. NO INJURIES HAVE OCCURRED AS A RESULT OF THIS PROBLEM, BUT IT DOES POSE A POTENTIAL INJURY OR CHAMBER DAMAGE RISK IF AN INATTENTIVE OPERATOR FAILS TO PROPERLY ALIGN THE RAILS. WE HAVE DIRECTED ALL OF OUR UNITS OPERATING 3200 SERIES CHAMBERS TO PERIODICALLY INSPECT THE RAILS AND CRADLE ASSEMBLY FOR LOOSENESS OR INSTABILITY. I HAVE REASSEMBLED ALL OF OUR AFFECTED UNITS BUT HAVE NOT USED ANY LOCK-TITE PENDING YOUR RECOMMENDATION OF SPECIFIC TYPE."