BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3063349 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01054
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 21, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE BATTERY LATCH DID NOT ALLOW THE BATTERY TO REMAIN INSERTED IN THE DEVICE. THERE WAS NO REPORTED PT INVOLVEMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY LATCH DID NOT ALLOW THE BATTERY TO REMAIN INSERTED IN THE DEVICE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125253 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1