Description of Event or Problem · 1
VENTILATOR DEPENDENT RESIDENT IN RESPIRATORY DISTRESS UNABLE TO SUMMON HELP DUE TO CALL BELL NOT FUNCTIONING. NOTICED BY PASERBY - CYANOTIC, AGITATED FI0/2 INCREASED TO TREAT DESATURATION WITH SUCCESS. FACILITY MANTENANCE EXAMINED AND REPLACED CALL BELL. COMPANY RESPRESENTATIVES ON SITE THE NNEXT DAY. ALL CALL BELLS AND BASIC SYSTEM CHECKED. BROKEN WIRE IN CALL BELL REPAIRED AS NEEDED. SPARE CALL BELLS SUPPLIED. PER DISTRIBUTOR, MAY HAVE BEEN CAUSED BY LIGHTNING DAMAGE, TWISTING OF CORD OR IMPROPER WIRE STRIPPING PRIOR TO SOLDERINGDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.