BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 4213919 · Received October 7, 2014

    Report

    Report Number
    1218950-2014-06059
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    September 12, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BATTERY FAILURE WAS OBSERVED. THE BATTERY GAVE A LOW BATTERY MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629920 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1