BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I

    MDR report key: 16460611 · Received March 1, 2023

    Report

    Report Number
    8010042-2023-00449
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 1, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K191027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN FINALIZED. BASED ON THE INFORMATION COLLECTED TO DATE, THE PROVIDED PROBLEM DESCRIPTION AND THE INSPECTION OF THE DEVICE CONDUCTED BY THE TECHNICIAN, IT HAS BEEN CLARIFIED THAT THE INITIALLY CLAIMED SYSTEM CHECKOUT FAILURE (SCO), HAS BEEN CAUSED BY O-RINGS FOR WATER TRAP RECEPTACLE MALFUNCTION. THE UNIT DID NOT PASS FOLLOWING TESTS: AUTO VENTILATION LEAKAGE, MAN VENTILATION LEAKAGE AND GAS ANALYZER. THE TECHNICIAN CHECK THE PART, REPLACED IT AND TESTED THE DEVICE. ALL TEST PASSED AND THE DEVICE WAS RETURNED FOR USE. THERE WERE NO FURTHER FAILURES. THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. MALFUNCTION OF WATER TRAP RECEPTACLE O-RINGS WILL BE DETECTED DURING INSTALLATION AND CONSECUTIVE SCO IF PRESENT. THIS ISSUE WILL NOT AFFECT VENTILATION OR AGENT DELIVERY DURING TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921362 FLOW-I GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB FLOW-I C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown