Description of Event or Problem · 1
ON MARCH 24, 1992, A CABLETRON MULTIPORT TRANSCEIVER WAS FOUND SMOKING IN ICU. THIS IS USED TO INTERFACE ALL SPACELABS MONITORS IN ICU. IF THIS TRANSCEIVER HAD FAILED COMPLETELY, COMMUNICATION WOULD HAVE BEEN LOST BETWEEN THE BEDSIDE MONITORS AND THE CENTRAL STATION AND RECORDERS. FAILED UNIT WAS REPLACED WITH A NEW MODLE MANUFACTURED BY ALLIED TELESIS, MODEL AT-810. THESE UNITS ARE USED WITH SPACELABS MONITORING SYSTEMSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.