BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2102349 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01413
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE DISPLAYED THE DEFIB FAILURE CYCLE POWER MESSAGE/INSTRUCTION WITH ASSOCIATED ERROR CODE 00040 UPON POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE MALFUNCTION. THE MALFUNCTION WAS RESOLVED BY REPLACEMENT OF THE CONTROL PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DISPLAYED THE DEFIB FAILURE CYCLE POWER MESSAGE/INSTRUCTION WITH ASSOCIATED ERROR CODE 00040 UPON POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT OR NEGATIVE PT IMPACT.

    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