BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 3143258 · Received May 23, 2013

    Report

    Report Number
    9610816-2013-00108
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO COMPLETE PERFORMANCE TESTING AND TO GATHER LOGS FILES. THE BEDSIDE AND CENTRAL STATION DEVICES WERE TESTED AND PROVIDED ALARMS BOTH AUDIBLY AND VISUALLY FOR ECG AND SP02 SIMULATIONS. THE LOGS WERE REVIEWED AND SHOW THAT A BRADY ALARM OCCURRED AT 15:08:09 AND WAS SILENCED 2 SECONDS LATER. A DESAT ALARM OCCURRED AT 15:08:40 WHICH WAS THEN SUSPENDED 3 SECONDS LATER. NO MALFUNCTION OCCURRED. ALARMS WERE SILENCED AND SUSPENDED WITHIN SECONDS OF OCCURRING. DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES ALARM BEHAVIOR WHEN ACKNOWLEDGING ALARMS. TRENDING FOR THIS ISSUE SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM DURING A DESAT EVENT. THE PATIENT REQUIRED EMERGENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228465 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1