BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 7215576 · Received January 24, 2018

    Report

    Report Number
    8020893-2018-00042
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 9, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) NUMBER ADDED TO SECTION D. CORRECTION TO EVALUATION CODES METHOD, RESULT AND CONCLUSION. CORRECTION TO THE PMA / 510K #. DEVICE EVALUATION: THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB) WAS RETURNED FOR FAILURE INVESTIGATION. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED COMPONENT, NO ANOMALIES WERE OBSERVED. THE BD PCB WAS ATTACHED TO THE FAILURE INVESTIGATION (F.I) TEST VENTILATOR AND DURING VENTILATION, UNIT GENERATED A VENTILATOR INOP CONDITION. INVESTIGATIONS INDICATE THAT THIS FAULT WAS CAUSED BY ALLIANCE MANUFACTURED DRAM DEVICES. ALLIANCE MANUFACTURED DEVICES WERE DISCONTINUED AND REPLACED BY OKI MANUFACTURED DEVICES FOR NEW BD PCBS FROM THE (B)(6) 2005 BECAUSE OKI DRAM DEVICES HAVE A HIGHER RELIABILITY THAN THE ALLIANCE PARTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AN 840 VENTILATOR WENT INTO INOPERABLE CONDITION WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59648 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1