BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1913734 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02375
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PATIENT CONNECTOR DID NOT WORK PROPERLY BECAUSE THERE WAS NOT A GOOD CONNECTION. THIS WAS FOUND IN TESTING ONLY. THERE WAS NO PATIENT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE. THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO THE EXTERNAL PADDLES CONNECTOR. REPLACING THE EXTERNAL PADDLE SET RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT CONNECTOR DID NOT WORK PROPERLY BECAUSE THERE WAS NOT A GOOD CONNECTION. THIS WAS FOUND IN TESTING ONLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1