BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 4251558 · Received September 3, 2014

    Report

    Report Number
    1218950-2014-05321
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Report Date
    August 14, 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

    PR#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE AFTER PREVENTATIVE MAINTENANCE A BATTERY WAS ORDERED. THERE WAS NO SYMPTOM OR ALLEGATION OF A FAILURE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535974 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1