BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART HOME

    MDR report key: 3050658 · Received March 14, 2013

    Report

    Report Number
    3030677-2013-00442
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NSA
    PMA / PMN Number
    K040904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED AS ISSUE COULD NOT BE CLEARED BY OPERATOR. DUE TO AGE OF DEVICE, WILL NOT BE REPLACED. CUSTOMER HAS BEEN ADVISED TO REMOVE FROM SERVICE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108486 HEARTSTART HOME NSA PHILIPS MEDICAL SYSTEMS M5068A

    Patients

    Seq Age Sex Outcome Treatment
    1