BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2083201 · Received April 13, 2011

    Report

    Report Number
    9610816-2011-00196
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 25, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT THE CUSTOMER EXPECTED A HEART RATE ALARM DURING PATIENT MONITORING. ACCORDING TO THE CUSTOMER, THE CLINICAL STAFF NORMALLY KEEP THE PULSE RATE AS THE ACTIVE ALARM SOURCE. WHEN THE ALARM SOURCE IS SET TO PULSE, ALL ARRHYTHMIA AND ECG HEART RATE ALARMS ARE SWITCHED TO OFF. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE ARE NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEMS OR ANY HEALTH RISK. THERE HAVE BEEN NO FURTHER SIMILAR REPORTS RECEIVED FROM THE CUSTOMER. DEVICE LABELING ADEQUATELY DESCRIBES ALARMING AVAILABLE USING DIFFERENT PARAMETER SOURCES. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY EXPECTED A HEART RATE ALARM WHILE MONITORING THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1