BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 4250297 · Received November 6, 2014

    Report

    Report Number
    1218950-2014-06708
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 16, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BATTERY TEST FAILURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714936 HEARTSTART SLA BATTERY DQA MKJ LDD DRO DQA PHILIPS MEDICAL SYSTEMS M3516A 57044-476

    Patients

    Seq Age Sex Outcome Treatment
    1