BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 13955199 · Received March 30, 2022

    Report

    Report Number
    1314417-2022-00010
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 30, 2022
    Manufacturer
    SUNMED LLC
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE LEAK COULD POTENTIALLY LOWERED VOLUME DELIVERED TO PATIENT.

    Additional Manufacturer Narrative · 0

    REPORTABLE LEAK COULD POTENTIALLY LOWERED VOLUME DELIVERED TO PATIENT. THIS ISSUE HAS BEEN ADDRESSED IN THE FIELD AND THE CUSTOMER IS COMFORTABLE WITH THE PRODUCT. DURING A FIELD VISIT THE CLINICIAN COULDN'T REPRODUCE THE ISSUE AND DIDN'T SAVE THE PRODUCT IN QUESTION. TRISTAR SKYLINE MEDICAL CENTER IS THE CUSTOMER. COULD NOT LOCATE ACCOUNT IN SALESPAD. CUSTOMER COMPLAINED ABOUT DEVICE LEAKING. THE ISSUE COULD NOT BE REPLICATED DURING A FIELD VISIT WITH THE CLINICIAN. NO CUSTOMER ACTION REQUIRED. RA: MULTIPLE HAZARD EFFECTS LISTED IN RMA-20020 FOR FUNCTIONAL ISSUES. COMPLETE INVESTIGATION COULD NOT BE DONE WITHOUT RETURNED PRODUCT OR REPEATED SCENARIO.

    Description of Event or Problem · 0

    LEAKING EXHALATION VALVE.

    Description of Event or Problem · 0

    LEAKING EXHALATION VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209153 SUNMED HOLDINGS LLC SMALL ADULT RESUS BAG W/MASK AND BAG RESERVOIR BTM SUNMED LLC AF5000MB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other