BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1960819 · Received December 17, 2010

    Report

    Report Number
    1218950-2010-02654
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE DEFIBRILLATOR FAILED TO POWER ON. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE DEFIBRILLATOR FAILED TO POWER ON. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1