BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 4903488 · Received July 9, 2015

    Report

    Report Number
    3030677-2015-01595
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    June 24, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTS THAT A REPLACEMENT BATTERY RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS SELF-TEST. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447003 HEARTSTART FRX AED MKJ PHILIPS MEDICAL SYSTEMS 861304

    Patients

    Seq Age Sex Outcome Treatment
    1