BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX 3 WIRE (SNAP) AAMI

    MDR report key: 4232385 · Received October 23, 2014

    Report

    Report Number
    1218950-2014-06307
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Report Date
    September 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE WAS NOT ABLE TO ACQUIRE A 12-LEAD DURING PATIENT TRANSPORT. THE CUSTOMER ALSO BELIEVED THAT THE ECG CONNECTOR APPEARED LOOSE. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674542 HEARTSTART MRX 3 WIRE (SNAP) AAMI DRO, LDD, MKJ MKJ PHILIPS MEDICAL SYSTEMS M3526A 4/2011

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR