ADAPTABLE BEACH CHAIR

Description of Event or Problem

WHILE PLACING THE PATIENT ONTO THE BEACH CHAIR, THE BASE SEPARATED FROM THE ASSEMBLY AT THE WELDED JOINT. FAILURE OCCURRED DURING PATIENT POSITIONING; NO PATIENT CONTACT WITH THE FAILURE POINT AND NO INJURY RESULTED. A REPLACEMENT DEVICE WAS PROVIDED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED AFTER THE 30-CALENDAR-DAY REPORTING TIMEFRAME REQUIRED UNDER 21 CFR 803.50. THE DELAY RESULTED FROM AN INITIAL REPORTABILITY DETERMINATION OF "NON-REPORTABLE" AT THE TIME OF COMPLAINT CLOSURE; THAT DETERMINATION HAS BEEN REASSESSED IN LIGHT OF THE MALFUNCTION RECURRENCE PATTERN ESTABLISHED ACROSS COMPLAINTS 86, 89, AND 91, AND THIS REPORT REFLECTS THE CORRECTED DETERMINATION.THIS REPORT REFLECTS A REASSESSMENT OF REPORTABILITY. THE EVENT (BASE SEPARATION AT THE WELDED JOINT OF THE INNER NESTED CHANNEL ASSEMBLY, (b)(4), LOT 2023032001, S/N (b)(4)) OCCURRED WHILE THE PATIENT WAS BEING PLACED ONTO THE DEVICE. NO PATIENT CONTACT WITH THE FAILURE POINT OCCURRED AND NO INJURY RESULTED; A REPLACEMENT DEVICE WAS PROVIDED.THIS WAS THE THIRD COMPLAINT OF THIS TYPE RECEIVED BY THE FIRM (RELATED MDR REPORT NUMBERS (b)(4) AND (b)(4)), AND ITS RECURRENCE DIRECTLY PROMPTED INITIATION OF CAPA-051. ROOT CAUSE INVESTIGATION DETERMINED THE FAILURE TO RESULT FROM INCONSISTENT/INADEQUATE WELD QUALITY AT THE BC-0105 JOINT. THIS REASSESSMENT IS WHY THE EVENT NOW MEETS THE MALFUNCTION RECURRENCE THRESHOLD UNDER 21 CFR 803.50.CORRECTIVE ACTION CONSISTS OF A MODULAR TWO-PART REDESIGN ELIMINATING THE WELDED JOINT, WITH ASSOCIATED PACKAGING REDESIGN; DESIGN VERIFICATION IS IN PROGRESS UNDER DCO 1052. A FIELD CORRECTION ADDRESSING ALL AFFECTED UNITS (21 CFR PART 806) IS IN PROCESS; THE ASSOCIATED CORRECTION/REMOVAL REPORT IS PENDING SUBMISSION.