BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8845448 · Received July 31, 2019

    Report

    Report Number
    8010042-2019-00560
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 29, 2019
    Report Date
    April 30, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS ASSISTED THROUGH A PHONE CALL FOR THIS COMPLAINT. THE REPORTED TECHNICAL ALARM INDICATES THAT THE SAFETY VALVE WAS OPEN AND ACCORDING TO SERVICE MANUAL FIRST REMEDY TO SOLVE THIS PROBLEM IS TO CHECK THE INSPIRATORY CHANNEL. AFTER THE CUSTOMER TOOK THIS RECOMMENDED ACTION AND CLEANED THE INSPIRATORY CHANNEL/PIPE, IT WAS REPORTED THAT THE ALARM DID NOT APPEAR AGAIN. THE VENTILATOR PASSED ALL THE SAFETY TESTS AND RETURNED TO CLINICAL USE. THERE WAS NO VENTILATOR MALFUNCTION. H3 OTHER TEXT : 4117

    Description of Event or Problem · 0

    MANUFACTURER REF.: 232767.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642957 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1