BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPONENT MONITORING SYSTEM (FLATSCREEN)

    MDR report key: 3230003 · Received July 10, 2013

    Report

    Report Number
    9610816-2013-00151
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    July 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    PMA / PMN Number
    K002758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR NUMBER: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A NON-INVASIVE BLOOD PRESSURE MEASUREMENT WAS TAKEN ON A PATIENT AFTER A SURGICAL PROCEDURE. THE NEXT MORNING, THEY FOUND THE PATIENT'S FOREARM WAS ISCHEMIC AND THE CUFF HAD NOT BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315997 COMPONENT MONITORING SYSTEM (FLATSCREEN) DRT PHILIPS MEDICAL SYSTEMS M1167A

    Patients

    Seq Age Sex Outcome Treatment
    1