BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2891783 · Received November 28, 2012

    Report

    Report Number
    1218950-2012-03942
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    November 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ISOLATED THE ISSUE TO A DEFECTIVE BATTERY LATCH ASSEMBLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE CUSTOMER REPLACED THE BATTERY LATCH ASSEMBLY WHICH RESOLVED THE ISSUE. THE DEVICE WAS TESTED AND PLACED BACK INTO SERVICE. WE WILL CONSIDER THIS A MALFUNCTION OF THE BATTERY LATCH ASSEMBLY WHERE THE BATTERY KEPT POPPING OUT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY KEEPS POPPING OUT OF THE BATTERY BAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1