BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-AIR

    MDR report key: 17019277 · Received May 30, 2023

    Report

    Report Number
    8010042-2023-01025
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 28, 2023
    Report Date
    May 30, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710003114
    PMA / PMN Number
    K192604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CLAIMED THAT INTERNAL LEAKAGE TEST FAILED. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND SERVICE REPORT. THERE WAS NO PATIENT INVOLVEMENT. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, THE INSPIRATORY PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD (PCB) HAS BEEN CHECKED AND REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL PERFORMANCE TESTS AND COULD BE RETURNED TO CLINICAL USE. PRESSURE TRANSDUCER PCB MEASURES THE PRESSURE, CONVEYED VIA THE PRESSURE TUBE CONNECTED TO THIS BLOCK BY ITS DIFFERENTIAL PRESSURE TRANSDUCER. DEFECTIVE PRESSURE TRANSDUCER PCB MAY LEAD TO HIGH PRESSURE.   IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, NEITHER THE DEVICE LOG NOR THE CLAIMED PART WERE AVAILABLE FOR FURTHER ANALYZE. THEREFORE, THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 830164

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618610 SERVO-AIR VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-AIR 07325710003114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown