BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIRCUITGUARD CIRCUITGUARD HME

    MDR report key: 748636 · Received July 20, 2005

    Report

    Report Number
    MW1036107
    Event Type
    Other
    Date Received
    July 20, 2005
    Report Date
    July 20, 2005
    Manufacturer
    ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    510-K- # K982239 WAS ISSUED FOR A PRODUCT THAT HAD A FILTER AND SLEEVE TO "REDUCE GROSS CONTAMINATION OF THE CIRCUT." THE PRODUCT CALLED CIRCUTGUARD IS BEING SOLD TO HOSPITALS TO "ASSURE SAFE REUSE OF ANESTHESIA BREATHING CIRCUTS" ARC MEDICAL LITERATURE # CGT1F 05/03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUITGUARD CIRCUITGUARD HME HEAT AND MOISTURE EXCHANGER AND FILTER CLASS II DEVICE BYD ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE NO NUMBER LISTED ON *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other