BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 14569757 · Received June 1, 2022

    Report

    Report Number
    2028807-2022-00014
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 10, 2022
    Report Date
    June 1, 2022
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10889483110850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE, HOWEVER THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. IF NOT CORRECTED IMMEDIATELY PATIENT WOULD BE IMPACTED AND SERIOUS HARM COULD OCCUR. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 0

    THE COMMITTEE ON TECHNOLOGY FOR THE ANESTHESIA PATIENT SAFETY FOUNDATION RECEIVED A REPORT REGARDING OUR HYPERINFLATION SYSTEM DESCRIBING THE DESIGN AS COUNTER-INTUITIVE AND THAT IT DOES NOT CONFORM WITH ISO STANDARD RECOMMENDATIONS. A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE, HOWEVER THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. THE PROBLEM WAS REMEDIED BY QUICK OBSERVATION THAT TO CLOSE THE VALVE, THE VALVE MUST BE TURNED ANTI-CLOCKWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265682 SUNMED HOLDINGS LLC 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER BTM SUNMED HOLDINGS LLC HS4011 210700765 10889483110850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other