BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3043151 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00889
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN INABILITY TO OBTAIN ETCO2 READINGS DURING A PT EVENT. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE ISSUE WAS ISOLATED TO A FAULTY ETCO2 MODULE. THE ETCO2 MODULE WAS REPLACED TO RESOLVE THE SYMPTOM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THIS WAS A MALFUNCTION OF THE ETCO2 MODULE THAT CAUSED AN INABILITY TO OBTAIN ETCO2 VALUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INABILITY TO OBTAIN ETCO2 READINGS DURING A PT EVENT. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106485 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1