BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO-PACE

    MDR report key: 2699033 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00009
    Event Type
    Other
    Date Received
    August 13, 2012
    Manufacturer
    PACE MEDICAL, INC.
    Product Code
    DTE
    PMA / PMN Number
    P920032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED DEVICE STATING THERE WAS A DIAGNOSTIC ERROR ON THE DISPLAY. THE DEVICE WAS ANALYZER AND THE FAULT COULD BE DUPLICATED. A CONNECTOR BETWEEN THE PRINTED CIRCUIT BOARD AND THE DISPLAY WAS LOOSE. THE CONNECTOR WAS REPLACED. THE DEVICE WAS RECALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. POTENTIAL REASON FOR OBSERVATION MAY HAVE BEEN ROUGH HANDLING OR SUDDEN IMPACT.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON MARCH 17, 2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-PACE TEMPORARY CARDIAC PACEMAKER DTE PACE MEDICAL, INC. 4570 NA

    Patients

    Seq Age Sex Outcome Treatment
    1