BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNICARE PATIENT MONITORING SYSTEM M1008A

    MDR report key: 553689 · Received October 20, 2004

    Report

    Report Number
    553689
    Event Type
    Other
    Date Received
    October 20, 2004
    Date of Event
    June 14, 2004
    Report Date
    October 20, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NINE REPORTS OF PATIENTS WITH VARIOUS POST-OPERATIVE INJURIES, INCLUDING NEUROPATHIES, EDEMA, BRUISING, PETECHIAE, BLISTERS, AND PAIN. ALL PATIENTS WERE OF VARIOUS AGES, GENDERS, SIZE, AND NATIONALITIES AND HAD UNDERGONE SURGICAL PROCEDURES OF VARYING TYPES AND LENGTHS. NO CONSISTENCIES WERE FOUND IN ANESTHESIA CARE PROVIDERS. ALL PATIENTS RECOVERED FROM THEIR INJURIES. SPECIFIC INFORMATION FOLLOW: THE PATIENT WAS IN THE SUPINE POSITION AND THE BLOOD PRESSURE CUFF WAS ON THE RIGHT FOREARM; THE CUFF WOULD NOT WORK ON THE UPPER ARM. THE CUFF WAS SET TO INFLATE EVERY 2.5 MINUTES FOR THE FIRST HALF OF THE CASE, THEN EVERY 5 MINUTES FOR THE SECOND HALF OF THE CASE. THE RIGHT HAND BECAME DARK WITH DECREASED SENSATION POST-OPERATIVELY. THE HAND REMAINED DISCOLORED WITH DECREASED SENSATION FOR SEVERAL DAY AND THEN SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNICARE PATIENT MONITORING SYSTEM M1008A PATIENT MONITORING SYSTEM MODULAR MHX PHILIPS MEDICAL SYSTEMS, INC M1008A (MODULEA) *
    2 OMNICARE PATIENT MONITORING SYSTEM M108B PATIENT MONITORING SYSTEM MODULAR MHX PHILIPS MEDICAL SYSTEMS, INC M1008B (MODULEB) *
    3 CRITIKON BLOOD PRESSURE CUFF BLOOD PRESSURE CUFF DXQ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *
    4 NOVAPLUS BLOOD PRESSURE CUFF BLOOD PRESSURE CUFF DXQ KIMBERLY CLARK CORPORATION * *
    5 REUSABLE COMFORT CUFFS M1573A-!575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS, INC * *
    6 REUSABLE COMFORT CUFFS M1573A-1575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS, INC * *
    7 REUSABLE COMFORT CUFFS M1573A-1575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR