BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3090260 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01390
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT TURN ON. NO PATIENT INVOLVEMENT WAS REPORTED. THE DEVICE WAS EVALUATED AT THE PHILIPS BENCH AND THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO A PROCESSOR PCA FAILURE. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL REQUIRED TESTING. WE ARE CONSIDERING THIS A MALFUNCTION OF THE PROCESSOR PCA. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT TURN ON. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169438 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1