BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM

    MDR report key: 2926179 · Received January 15, 2013

    Report

    Report Number
    9611500-2013-00003
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 11, 2013
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K092788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED. THE INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE MONITOR OF THE CHAMBER 108 SHOWED A WRONG BLOOD PRESSURE WRONG (+070MMHG). AS THE PATIENT HAD A BLOOD PRESSURE OF 130 MMHG DISPLAYED. IT WAS IN FACT 60 MMHG. BECAUSE OF WRONG MEASUREMENT, THE PATIENT RECEIVED ANTIHYPERTENSIVE TREATMENT THAT HAS RESULTED IN A HYPO BLOOD PRESSURE, CARDIAC ARREST AND ACR. PATIENT WAS TRANSFERRED TO THE CARDIAC SURGERY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22514 INFINITY ACUTE CARE SYSTEM PATIENT MONITOR CBK DRAEGER MEDICAL AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening