BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8934001 · Received August 27, 2019

    Report

    Report Number
    8010042-2019-00625
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Report Date
    February 18, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE WAS REQUESTED AND NO FURTHER INFORMATION FROM THE HOSPITAL WAS PROVIDED. NO PARTS WERE RETURNED FOR INVESTIGATION. THE CONSEQUENCE TO THIS KIND OF MECHANICAL DAMAGE IS THAT THE USER INTERFACE GETS DETACHED AND IN A WORST CASE FALLS OFF THE VENTILATOR CARRIER. OUR CONCLUSION IS THAT THE USER INTERFACE HAS BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 233707.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S USER INTERFACE HOLDER WAS DAMAGED. THERE WAS NO PATIENT HARM. MANUFACTURER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729623 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1