BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 6612542 · Received June 5, 2017

    Report

    Report Number
    8020893-2017-06397
    Event Type
    Injury
    Date Received
    June 5, 2017
    Date of Event
    May 6, 2017
    Report Date
    May 9, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE BATTERY PACK, BREATH DELIVERY (BD) POWER CONTROLLER PRINTED CIRCUIT BOARD (PCB), AND POWER DISTRIBUTION PCB WERE RETURNED TO MEDTRONIC¿S PRODUCT ANALYSIS LABORATORY. A VISUAL INSPECTION WAS PERFORMED ON THE BATTERY PACK, BD POWER CONTROLLER PCB, AND POWER DISTRIBUTION PCB. NO ANOMALIES WERE OBSERVED. AN INVESTIGATION WAS PERFORMED ON THE BATTERY PACK AND THE REPORTED ISSUE WAS NOT DUPLICATED. NO ERROR LOGS WERE RECORDED IN THE DIAGNOSTIC LOGS DURING TESTING. NO FAULT WAS FOUND WITH THE RETURNED BATTERY PACK. AN INVESTIGATION WAS PERFORMED ON THE BD POWER CONTROLLER PCB AND THE REPORTED ISSUE WAS NOT DUPLICATED. NO ERROR LOGS WERE RECORDED IN THE DIAGNOSTIC LOGS DURING TESTING. NO FAULT WAS FOUND WITH THE RETURNED BD POWER CONTROLLER PCB. AN INVESTIGATION WAS PERFORMED ON THE POWER DISTRIBUTION PCB AND THE REPORTED ISSUE WAS NOT DUPLICATED. NO ERROR LOGS WERE RECORDED IN THE DIAGNOSTIC LOGS DURING TESTING. NO FAULT WAS FOUND WITH THE RETURNED POWER DISTRIBUTION PCB. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED A BATTERY ALARM. 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 REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND DIAGNOSTIC CODES RELEVANT TO THE REPORTED INCIDENT RECORDED IN THE VENTILATORS MEMORY LOGS. THE SE REPLACED THE COMPRESSOR BATTERY, AND BREATH DELIVERY (BD) POWER CONTROLLER AND POWER DISTRIBUTION PRINTED CIRCUIT BOARDS (PCB)S. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392647 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention