BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8730758 · Received June 25, 2019

    Report

    Report Number
    8010042-2019-00431
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Report Date
    March 20, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF SIDE RAIL SEPARATED FROM THE MOBILE CART COULD NOT BEEN INVESTIGATED ON SITE SINCE THE CUSTOMER DID NOT REQUEST ANY SERVICE. WE HAVE RECEIVED PICTURES THAT DEPICT THE DISLODGED SIDE RAIL. NO PARTS WERE RETURNED FOR INVESTIGATION AND WE HAVEN'T NOT RECEIVED ANY FURTHER INFORMATION REGARDING THE STATUS OF THE RAIL. THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN CONFIRMED BUT IS MOST LIKELY RELATED TO AN OVERLOAD, OR MECHANICAL FORCE THAT IS ABOVE THE SPECIFICATION THE RAIL HAS BEEN DESIGNED FOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RAIL THAT SUPPORTS THE VENTILATOR CARRIAGE, WAS BROKEN. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 220592.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524495 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1