BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 12820062 · Received November 16, 2021

    Report

    Report Number
    8010042-2021-02711
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 16, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR NEGATIVE PEEP (POSITIVE END EXPIRATORY PRESSURE). IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND DEVICE'S LOGS. SERVICE REPORT WAS NOT AVAILABLE FOR FURTHER EVALUATION. BASED ON TECHNICIAN STATEMENT, THE ISSUE HAS BEEN SOLVED BY REPLACING O2 CELL. THE REPLACED PART WAS NOT RETURNED FOR FURTHER ANALYSIS, THEREFORE THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE CORRECTION OF FIELD #H4 DEVICE MANUFACTURE DATE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #H4 MANUFACTURE DATE: PREVIOUS MANUFACTURE DATE: 11/10/2003. CORRECTED MANUFACTURE DATE: 11/12/2003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD PEEP (POSITIVE END EXPIRATORY PRESSURE) ISSUES. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718045 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown