BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 2853846 · Received October 24, 2012

    Report

    Report Number
    1218950-2012-03546
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 28, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE SHUT DOWN DURING PACER TESTING WITHOUT WARNING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SLA BATTERY MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A P-2011-01

    Patients

    Seq Age Sex Outcome Treatment
    1