BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2885216 · Received December 17, 2012

    Report

    Report Number
    9610816-2012-00505
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEM
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ON (B)(6) 2012, AT AROUND 3 AM, THE MONITOR DID NOT ALARM FOR LOW INVASIVE PRESSURE RESULTING IN A SERIOUS INJURY TO THE PT. THE PT RECEIVED TREATMENT AFTER A RED ASYSTOLE ALARM OCCURRED. THE PT WAS TREATED WITH CPR AND SURVIVED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD¿L INFO 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 ON (B)(4) 2012, AT AROUND 3 AM, THE MONITOR DID NOT ALARM FOR LOW INVASIVE PRESSURE RESULTING IN A SERIOUS INJURY TO THE PT. THE PT RECEIVED TREATMENT AFTER A RED ASYSTOLE ALARM OCCURRED. THE PT WAS TREATED WITH CPR AND SURVIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1