BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 8784400 · Received July 12, 2019

    Report

    Report Number
    3004593495-2019-00682
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 28, 2019
    Report Date
    November 21, 2019
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    UDI-DI
    00643169725126
    PMA / PMN Number
    K150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: MANUFACTURER'S ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE EXTERNAL PULSE GENERATOR (EPG) OUTPUT CONNECTOR ASSEMBLY WAS BROKEN. IT WAS ALSO INDICATED THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION, THE HANGER ASSEMBLY WAS CRACKED, THE CASES WERE CONTAMINATED, THE MAIN LABEL WAS DAMAGED, THE MAIN SEAL WAS CONTAMINATED, A CASE SCREW WAS CONTAMINATED, AND A DISPLAY WIRE INSULATION WAS PINCHED, BUT THE WIRE WAS NOT EXPOSED. THE EPG WAS REPAIRED AND RETURNED TO USE. 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. BENCHTOP ANALYSIS: ASSEMBLED INTO A GOLDEN UNIT. RAN ON AUTOMATED TEST CONSOLE. FAILED ATRIAL PULSE NOISE TEST, 135.16 MV. 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 34.00 MV. 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 EXTERNAL PULSE GENERATOR (EPG) CONNECTOR PORT WAS DAMAGED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577385 DUAL CHAMBER TEMPORARY PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392 00643169725126

    Patients

    Seq Age Sex Outcome Treatment
    1