BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2121566 · Received May 4, 2011

    Report

    Report Number
    1218950-2011-01274
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 11, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE HEARTSTART XL BATTERY IS LOOSE AND UNSTABLE AND THAT THE UNIT UNEXPECTEDLY SHUTS DOWN. THERE WAS NO REPORT OF PATIENT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HEARTSTART XL BATTERY IS LOOSE AND UNSTABLE AND THAT THE UNIT UNEXPECTEDLY SHUTS DOWN. THERE WAS NO REPORT OF PATIENT 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