BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNICARE PATIENT MONITORING SYSTEM M1008A

    MDR report key: 553681 · Received October 20, 2004

    Report

    Report Number
    553681
    Event Type
    Other
    Date Received
    October 20, 2004
    Date of Event
    February 4, 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 SUPINE, THE CUFF WAS PLACED ON THE RIGHT UPPER EXTREMITY, AND RECEIVED NUMEROUS PETECHIAE BELOW THE LEVEL OF THE BLOOD PRESSURE CUFF.

    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 (MODULE A) *
    2 OMNICARE PATIENT MONITORING SYSTEM M1008B PATIENT MONITORING SYSTEM - MODULAR MHX PHILIPS MEDICAL SYSTEMS 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-1575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS * *
    6 REUSABLE COMFORT CUFFS M1573A-1575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS * *
    7 REUSABLE COMFORT CUFFS M1573A-1575A BLOOD PRESSURE CUFF DXQ PHILIPS MEDICAL SYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR