BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 5027442 · Received August 25, 2015

    Report

    Report Number
    2031642-2015-01654
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURERS SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPLACED THE MOTOR CONTROLLER BOARD AND CPU BOARD TO ADDRESS THE REPORTED PROBLEM. FAILURE ANALYSIS ON THE RETURNED MOTOR CONTROLLER (MC) BOARD AND CPU BOARD FOUND THAT CAPACITOR C187 ON THE MC BOARD AND C166 ON THE CPU BOARD HAD BOTH SHORTED, CAUSING THE 12 VOLT SUPPLY FAILURE. REPLACEMENT OF THE SHORTED CAP AT C166 (10UF/20V/TAN) CORRECTED THE PROBLEM WITH THIS CPU PCBA. REPLACEMENT OF THE SHORTED CAP C187 (22UF/25V/20%) CORRECTED THE PROBLEM WITH THIS MOTOR CONTROLLER (MC) BOARD. NO FURTHER INFORMATION RECEIVED FROM THIS CUSTOMER. THIS COMPLAINT WAS INITIATED DUE TO A MALFUNCTION OF THE DEVICE WHICH POSES A RISK OF PATIENT HARM; THE UNIT HAD A +12V POWER DELIVERY MALFUNCTION, WHICH WILL CAUSE THE UNIT TO SHUT DOWN AND EMIT AN ALARM. THE FSE WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT THAT THE UNIT WOULD NOT FUNCTION PROPERLY. TO FIX THE ISSUE, THE FSE REPLACED THE CPU AND MOTOR CONTROLLER (MC) BOARDS. THE CPU AND MC BOARDS WERE RETURNED FOR FAILURE INVESTIGATION (FI) WHICH DETERMINED CAPACITOR C187 ON THE MC BOARD AND C166 ON THE CPU BOARD HAD BOTH SHORTED, CAUSING THE 12 VOLT SUPPLY FAILURE. AS THE DEVICE ALARMED AS EXPECTED, THE DETERMINATION CANNOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE VENTILATOR WAS IN PATIENT USE WHEN THE MALFUNCTION OCCURRED, THERE WAS REPORTED HARM TO THE PATIENT. THE DEVICE IS USED FOR TREATMENT AND THERE IS A RELATIONSHIP OF THE DEVICE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE IN USE ON PATIENT. THE CUSTOMER REPORTED THAT THERE WAS PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE IN USE ON PATIENT. THE CUSTOMER REPORTED THAT THERE WAS PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560858 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention