BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3

    MDR report key: 9701272 · Received February 12, 2020

    Report

    Report Number
    3030677-2020-00289
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Report Date
    January 27, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838049994
    PMA / PMN Number
    K130684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    PART# CORRECTION: 861388, UDI# CORRECTION: (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE DID NOT RECOGNIZE A SIMULATED SHOCKABLE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167002 HEARTSTART FR3 AED MKJ PHILIPS MEDICAL SYSTEMS 861388 00884838049994

    Patients

    Seq Age Sex Outcome Treatment
    1