BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 2881006 · Received November 13, 2012

    Report

    Report Number
    1218950-2012-03759
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 19, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BATTERY FAILED THE CAPACITY TEST. THE PHILIPS QUALITY DEPARTMENT EVALUATED THE BATTERY AND FOUND THE BATTERY FAILURE ALSO CAUSED AN UNEXPECTED SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SLA BATTERY DQA MKJ LDD DRO DQA PHILIPS MEDICAL SYSTEMS M3516A R-2011-10

    Patients

    Seq Age Sex Outcome Treatment
    1