BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 8737019 · Received June 26, 2019

    Report

    Report Number
    3004593495-2019-00620
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 10, 2019
    Report Date
    September 19, 2019
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    UDI-DI
    00643169508767
    PMA / PMN Number
    K150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS ABLE TO CONFIRM THE OUTPUT CONNECTOR ASSEMBLY WAS BROKEN. ANALYSIS ALSO NOTED THAT THE EPG FAILED INCOMING TESTING DUE TO AN OUT OF ELECTRICAL SPECIFICATION MAIN PRINTED CIRCUIT BOARD (PCB). ADDITIONALLY, THE HANGER ASSEMBLY WAS CRACKED, THE UPPER CASE WAS CRACKED AT THE BOSS, THE LOWER CASE WAS CRACKED, AND THE DISPLAY WIRE WAS PINCHED WITHOUT COMPROMISED INSULATION. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS WAS PERFORMED ON THE MAIN BOARD. VISUAL INSPECTION: NO ANOMALIES. BENCHTOP ANALYSIS: ASSEMBLED INTO A GOLDEN UNIT. RAN ON AUTOMATED TEST CONSOLE. FAILED ATRIAL PULSE NOISE TEST, 175.03MV. MEASURED ATRIAL PULSE NOISE IS WITHIN THE REQUIREMENTS OF THE ATRIAL PULSE NOISE TEST (0-100 MV). MEASURED ATRIAL PULSE NOISE ON THE BENCH AT 52.38MV. LOGS ANALYZED, "810", "820", AND "722" ERRORS FOUND. CONFIRMED UNIT FAILS ATRIAL PULSE NOISE TEST, BUT ATRIAL PULSE NOISE LEVEL MEASURED IS WITHIN DEVICE SPECIFICATIONS. CONCLUSION: NO DEFECT FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR OUTPUT CONNECTOR ON THE EXTERNAL PULSE GENERATOR (EPG) WAS CRACKED. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528884 DUAL CHAMBER TEMPORARY PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392 00643169508767

    Patients

    Seq Age Sex Outcome Treatment
    1