BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO PACING/DEFIBRILLATION/ECG

    MDR report key: 161125 · Received March 31, 1998

    Report

    Report Number
    3015876-1998-00159
    Event Type
    Malfunction
    Date Received
    March 31, 1998
    Report Date
    March 31, 1998
    Manufacturer
    PHYSIO-CONTROL CORP
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THE FACILITY'S DEFIBRILLATORS, ALONG WITH 2 PAIR OF DISPOSABLE DIFIBRILLATION ELECTRODES, LOT CODE #K052097-2, (1 PAIR OPENED, 1 PAIR UNOPENED) WAS RETURNED TO PHYSIO-CONTROL FOR EVALUATION. IN AN EVALUATION OF THE RETURNED ELECTRODES AND DEVICE BY PHYSIO-CONTROL, PROPER OPERATION WAS OBSERVED WITH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE ELECTRODES WERE REPLACED AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE. PROPER DEVICE OPERATION WAS REVIEWED WITH THE CUSTOMER BY PHYSIO-CONTROL. EXCEPT AS PROVIDED BY 21 CFR 803.56, PHYSIO-CONTROL DOES NOT INTEND TO SUBMIT ADDITIONAL INFO ON THIS EVENT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS THAT IN THREE SEPARATE INSTANCES, THEIR DEVICES HAVE ALARMED "CONNECT ELECTRODES" WHEN AN ELECTRODE SET IS CONNECTED AND THE DEVICE POWERED ON. IN EACH CASE, CONNECTING A NEW SET OF ELECTRODES RELIEVES THE ALARM. NO ADVERSE AFFECTS TO PTS WERE REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-COMBO PACING/DEFIBRILLATION/ECG EXTERNAL PACING/DEFIBRILLATION/ECG LDD PHYSIO-CONTROL CORP NA K052097-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 3005400-000.| LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR, P/N