BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2043224 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00692
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 2, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE BATTERY COULD NOT BE CHARGED. THE CUSTOMER ISOLATED THE REPORTED ISSUE TO THE BATTERY. REPLACING THE BATTERY RESOLVED THE REPORTED ISSUE. WE WILL CONSIDER THIS A BATTERY MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY COULD NOT BE CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MKJ PHILIPS HEALTHCARE M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1