BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 2961056 · Received January 16, 2013

    Report

    Report Number
    1218950-2013-00195
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    December 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY HAD A RED CROSS MARK ON IT AND THE UNIT WAS BEEPING WITH A MESSAGE THAT MACHINE CANNOT BE USED FOR CLINICAL PURPOSES. THE HOSPITAL BIOMED RAN THE OP CHECK AND THE ISSUE WAS RESOLVED. THE ERROR LOG SHOWED 1:9 (PROCESSOR SUPPLY OUT OF RANGE) AND 1:24 (RFU STATUS MISMATCH) ERROR CODES. NO PATIENT INVOLVEMENT WAS REPORTED. 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 BATTERY HAD A RED CROSS MARK ON IT AND THE UNIT WAS BEEPING WITH A MESSAGE THAT MACHINE CANNOT BE USED FOR CLINICAL PURPOSES. THE HOSPITAL BIOMED RAN THE OP CHECK AND THE ISSUE WAS RESOLVED. THE ERROR LOG SHOWED 1:9 (PROCESSOR SUPPLY OUT OF RANGE) AND 1:24 (RFU STATUS MISMATCH) ERROR CODES. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25180 HEARTSTART XL + DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1