BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8901412 · Received August 16, 2019

    Report

    Report Number
    8010042-2019-00598
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 15, 2020
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR SHUTS OFF WITH CONSTANT ALARM. OUR FIELD SERVICE ENGINEER VERIFIED THAT THE USER INTERFACE WAS BLANK AND THE VENTILATOR WAS CONSTANTLY ALARMING. AFTER INVESTIGATION, HE FOUND THAT THE CONTROL CABLE AND THEDC/DC & STANDARD CONNECTORS PRINTED CIRCUIT BOARD (PCB) SOCKET WHERE DAMAGED. HE REPLACED THE DC/DC & STANDARD CONNECTORS PCB AND CONTROL CABLE AFTER WHICH THE VENTILATOR WORKED ACCORDING TO ITS SPECIFICATION. NO PART WAS RETURNED. THE EXTENT OF THE DAMAGE TO THE DC/DC & STANDARD CONNECTORS PCB IS NOT KNOWN. A DAMAGE TO THE CONTROL CABLE AND ITS CONNECTIONS ONLY WILL NOT AFFECT ONGOING VENTILATION. IF AN INTERNAL POWER FAILURE RELATED TO THE DC/DC & STANDARD CONNECTORS PCB OCCURS DURING VENTILATION IT MAY LEAD TO STOP OF VENTILATION. ALARMS WILL BE GENERATED. THE CONCLUSION IN THIS MATTER IS THAT OUR FIELD SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND FOUND THAT THE CONTROL CABLE AND THE DC/DC & STANDARD CONNECTORS PCB SOCKET WHERE DAMAGED. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: 231166.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUTS OFF WITH CONSTANT ALARM. PATIENT INVOLVEMENT IS UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696337 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1