Description of Event or Problem · 1
ALARM VOLUMN WAS SET AT 50 DB LEVEL. ALARM LIMITS WERE INCREASED TO MAX SO THAT ALARM COULD BE HEARD WITHIN THE UNIT. INCIDENT CAUSED BY DISCONNECT OF CIRCUIT FROM PATIENT. ALARMS DETECTED AT 1519. UNIT WAS TESTED AND FOUND OPERATIONAL. IT IS POSSIBLE DISCONNECT CAUSED BY PTIENT EVENT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, OTHER. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.