BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 4841139 · Received June 12, 2015

    Report

    Report Number
    3030677-2015-01441
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    June 3, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385675 HEARTSTART FRX AED MKJ PHILIPS MEDICAL SYSTEMS 861304

    Patients

    Seq Age Sex Outcome Treatment
    1