BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM

    MDR report key: 2243813 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00439
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 5, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A DEVICE FELL AND WAS BROKEN. NO PT HARM WAS REPORTED. IN THE ABUNDANCE OF CAUTION, PHILIPS IS REPORTING THIS AS IT IS UNK WHETHER THIS FALL WAS RELATED TO A PRODUCT MALFUNCTION AND NOT SIMPLY AN ACCIDENTAL FALL. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A MONITOR FELL AND WAS BROKEN. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM MHX PHILIPS MEDICAL SYSTEMS M3000A

    Patients

    Seq Age Sex Outcome Treatment
    1