BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2935237 · Received January 22, 2013

    Report

    Report Number
    9610816-2013-00008
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    PHILIPS MED SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT PT HAD AN ASYSTOLE CONDITION, BUT NO ALARM OCCURRED AT THE CENTRAL MONITOR. THE CUSTOMER STATED THAT THERE WAS A NURSE IN THE ROOM AT THE TIME SO THERE WAS NO DELAY IN TREATMENT. THE PT WAS RESUSCITATED HOWEVER THE PT LATER EXPIRED. THE MONITOR WAS EVALUATED BY THE HOSPITAL BIOMED WHO STATED THAT THE MONITOR WAS OPERATING NORMALLY. LOGS WERE PROVIDED AND REVIEWED. THE LOGS SHOWED THAT MULTIPLE ALARMS DID OCCUR INCLUDING ASYSTOLE ALARMS AT THE TIME OF THE EVENT. THE ALARMS WERE SUSPECTED BY A USER AT THE BEDSIDE. THE AVAILABLE INFO SUPPORTS THAT THE USERS WERE AWARE OF THE PT'S STATUS AND THAT THERE WAS NO DEVICE MALFUNCTION. DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES ALARM BEHAVIOR FOR PAUSING OR SUSPENDING ALARMS. THE BIOMED RECEIVED THE RESULTS OF THE LOG DATA REVIEW. TRENDING FOR THIS ISSUE SUPPORTS THAT THERE WAS NO MALFUNCTION OR HEALTH RISK AND THERE ARE NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMS DID NOT SOUND FOR A PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31466 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MED SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death