BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063445 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01143
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    July 18, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED "DOWN". THE SYMPTOM WAS LATER CLARIFIED TO BE THAT THE DEVICE WOULD NOT POWER ON NORMALLY. THE DEVICE WAS EVALUATED LOCALLY BY PHILIPS AND THE REPORTED SYMPTOMS WAS CONFIRMED. MULTIPLE PARTS WERE REPLACED TO RESOLVE THE REPORTED SYMPTOM. AFTER PASSING ALL REQUIRED TESTING THE DEVICE WAS RETURNED INTO USE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "DOWN". THE SYMPTOM WAS LATER CLARIFIED TO BE THAT THE DEVICE WOULD NOT POWER ON NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127315 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1