ADAPTABLE BEACH CHAIR

Description of Event or Problem

DURING POSITIONING OF THE PATIENT, THE TOP PIECE OF THE BEACH CHAIR (WHICH SUPPORTS THE PATIENT'S HEAD) BROKE OFF THE BASE AT THE WELDED CONNECTION AND WAS FULLY DISCONNECTED. THE EVENT OCCURRED WHILE THE PATIENT WAS ANESTHETIZED ON THE TABLE, JUST BEFORE DRAPING AND THE START OF THE PROCEDURE. NO PATIENT INJURY OCCURRED; THE EVENT CAUSED A DELAY TO THE SURGERY. THE FAILURE MODE IS LOSS OF HEAD SUPPORT DUE TO FRACTURE OF THE BC-0105 WELD.

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 (HEADREST SEPARATION AT THE WELDED CONNECTION OF THE INNER NESTED CHANNEL ASSEMBLY, BC-0105, LOT 2023071801, S/N(b)(4)) OCCURRED DURING PATIENT POSITIONING, PRIOR TO DRAPING, WITH THE PATIENT ASLEEP ON THE TABLE. NO PATIENT CONTACT WITH THE FAILURE POINT OCCURRED; THE PROCEDURE WAS DELAYED WHILE A REPLACEMENT DEVICE WAS OBTAINED. NO INJURY RESULTED.AT THE TIME OF INITIAL INVESTIGATION, DEVICE DAMAGE (BENDING, SCRATCHING) WAS ATTRIBUTED TO IMPROPER HANDLING AND SHIPPING. ROOT CAUSE INVESTIGATION UNDER CAPA-051, INFORMED BY THE PATTERN ESTABLISHED ACROSS COMPLAINTS 86, 89, AND 91 (RELATED MDR REPORT NUMBERS 3019856155-2026-00001 AND -00003), DETERMINED THE UNDERLYING ROOT CAUSE TO BE INCONSISTENT/INADEQUATE WELD QUALITY AT THE BC-0105 JOINT, WITH PACKAGING/TRANSIT CONDITIONS AS A CONTRIBUTING RATHER THAN PRIMARY FACTOR. 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.