BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2091271 · Received April 20, 2011

    Report

    Report Number
    1218950-2011-01081
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 22, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE UNEXPECTEDLY SHUT DOWN AND NOW THE DEVICE FAILS TO POWER UP (WITH ANY COMBINATION OF AC AND BATTERY POWER). THIS REPORTED ISSUE WAS FOUND DURING INCOMING INSPECTION OF THE DEVICE UPON ORIGINAL RECEIPT OF THE DEVICE; THERE WAS NO PATIENT INVOLVEMENT. 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, THE DEVICE UNEXPECTEDLY SHUT DOWN AND NOW THE DEVICE FAILS TO POWER UP (WITH ANY COMBINATION OF AC AND BATTERY POWER). THIS REPORTED ISSUE WAS FOUND DURING INCOMING INSPECTION OF THE DEVICE UPON ORIGINAL RECEIPT OF THE DEVICE; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1