BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNICARE PATIENT MONITORING SYSTEM M1008A

    MDR report key: 553684 · Received October 1, 2004

    Report

    Report Number
    553684
    Event Type
    Other
    Date Received
    October 1, 2004
    Date of Event
    January 8, 2004
    Report Date
    October 1, 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 INJURIES POST-OP 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 PLACED IN SUPINE POSITION, THE CUFF WAS PLACED ON THE RIGHT UPPER ARM. THE PATIENT EXPERIENCED MUSCULOCUTANEOUS NEUROPATHY, WEAKNESS AND PARASTHESIAS IN DISTRIBUTION OF MUSCULOCUTANEOUS NERVE.

    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 SYSTEMS, INC. PATIENT MONITORING SYSTEM-MODULAR MHX PHILIPS MEDICAL SYSTEMS, INC. M1008B (MODULE B) *
    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, 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 * OTHER