Description of Event or Problem · 1
CHAIR CHECK BY BED-CHECK CORP. 1. ORDERED UNIT 1/23/92 FOR FENNICHIA. 2. UNIT ARRIVED 2/6/92. FENNICHIA'S BALANCE MUCH BETTER. UNITS ARE INAPPROPRIATE FOR HER USE. 3. 2/11/92 - INSTALLED UNIT ON WEIKEL'S CHAIR ACCORDING TO INSTRUCTIONS, WHICH SHOWS IT ON SLING SEAT WHEELCHAIR. UNIT FUNCTIONED WELL 2/11 DAYS AND EVENING SHIFTS. 4. 2/12/92. UNIT DID NOT GO OFF XL WHEN PATIENT LEFT CHAIR. O.T. CHECKED BATTERY AND SENSORY PAD- ALL INTACT. PT CALLED BED CHECK CORP. AND TOLD GREG HONIFEN IN ENGINEERING OF MALFUNCTION. HE SAID SOMETIMES PAD CREASE CAUSES MALFUNCTION. SENSOR PAD WAS NOT CREASED. GREG AIR SHIPPED A NEW UNIT AND A NEW SENSOR PAD TO DSH PHYSICAL THERAPY DEPARTMENT. O.T. INFORMED STAFF NOT TO RELY ON UNIT AS SOLE MEANS OF ALERTING THEM TO PATIENT'S EXITING CHAIR. ON 2/13/92 UNIT MALFUNCTIONED AT LEAST THREE TIMES. FROM 2/25/92 TO 2/26/92 UNIT CONTINUES TO MALFUNCTION (ALARM SYSTEM)DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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, A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, ALARM FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.