BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 3100013 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01464
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER ISOLATED THE ISSUE TO THE BATTERY. THE CUSTOMER REPLACED THE BATTERY WHICH RESOLVED THE ISSUE. THE AGE OF THE BATTERY WAS UNKNOWN. WE WILL CONSIDER THIS A MALFUNCTION OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY FAILED THE CAPACITY TEST WHERE THE LOW BATTERY WARNING WAS ONLY 23 SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182181 HEARTSTART SLA BATTERY MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1