BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 4820612 · Received June 5, 2015

    Report

    Report Number
    3030677-2015-01345
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 22, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HS1 WILL NOT PASS THE BIT. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365955 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1