BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLLNTP

    MDR report key: 458 · Received April 15, 1992

    Report

    Report Number
    458
    Event Type
    Malfunction
    Date Received
    April 15, 1992
    Date of Event
    March 17, 1992
    Report Date
    April 1, 1992
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT IN 3RD DEGREE HEART BLOCK INTRANSFER TO TERTIARY CARE FACILITY. PACEMAKER STOPPED FUNCTIONING AFTER APPROXIMATELY 30-45 MINUTES. HEARTRATE DECREASED TO 30-40. PATIENT DID ARRIVE AT TERTIARY CARE FACILITY WITHOUT PROBLEMDEVICE 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-DEC-91. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, BATTERY FAILURE - ACCELERATED DEPLETION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLLNTP NONINVASIVE TEMPORARY PACEMAKER DRO ZMI CORPORATION NTP 1000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other