BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3

    MDR report key: 4736640 · Received April 27, 2015

    Report

    Report Number
    3030677-2015-01049
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Report Date
    April 7, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K130684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR. 510(K): K111693.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED IS NOT FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS THE SELF-TEST. THERE WASN'T ANY NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276515 HEARTSTART FR3 AED MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1