BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3040497 · Received February 6, 2013

    Report

    Report Number
    1218950-2013-00413
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 21, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER REPORTED THAT A SYNCHRONIZED SHOCK WAS NOT DELIVERED. THERE WAS NO REPORT OF ANY NEGATIVE PT IMPACT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT A SYNCHRONIZED SHOCK WAS NOT DELIVERED. THERE WAS NO REPORT OF ANY NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51664 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1