BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 4182257 · Received August 4, 2014

    Report

    Report Number
    1218950-2014-04534
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    October 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IT WAS NOT PASSING TEST, SLOW TO START, AND NOTHING WAS ON SCREEN. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453803 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A >5 YRS OLD

    Patients

    Seq Age Sex Outcome Treatment
    1