BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 4844531 · Received June 15, 2015

    Report

    Report Number
    3030677-2015-01446
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    June 2, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Removal / Correction Number
    Z-0642-2013, Z-0643-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387162 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1