BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2102603 · Received May 20, 2011

    Report

    Report Number
    1218950-2011-01428
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE DISPLAYED ERROR CODE 10003 AND THE CYCLE POWER MESSAGE/INSTRUCTION. THERE WAS NO REPORT OF PT IMPACT OR NEGATIVE PT INVOLVEMENT. PHILIPS SVC CTR. WORKED WITH THE CUSTOMER AND DETERMINED THAT THE CAUSE OF THE ISSUE WAS THE EXTERNAL MEMORY CARD. REPLACEMENT OF THE EXTERNAL DATA CARD RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DISPLAYED ERROR CODE 10003 AND THE CYCLE POWER MESSAGE/INSTRUCTION. THERE WAS NO REPORT OF PT IMPACT OR NEGATIVE PT 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