BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VM 4 PATIENT MONITOR

    MDR report key: 2272558 · Received September 21, 2011

    Report

    Report Number
    1218950-2011-02634
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Report Date
    September 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF AUDIO. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT 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 THERE WAS A LOSS OF AUDIO. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESIGNS VM 4 PATIENT MONITOR MHX PHILIPS HEALTHCARE - ANDOVER 863063

    Patients

    Seq Age Sex Outcome Treatment
    1