BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8409725 · Received March 11, 2019

    Report

    Report Number
    2031642-2019-01406
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Report Date
    February 14, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 30MAY2019. DATE REC¿D BY MFR: 29MAY2019. THE REPORTED ISSUE PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED THE PHILIPS FIELD SERVICE ENGINEER (FSE) RETURNED THE DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY (DAQ PCBA). THE FSE ALSO REPLACED SOLENOIDS 3 AND 4 BUT DID NOT RETURN THEM FOR INVESTIGATION. A DAQ PCBA WAS RETURN FOR ANALYSIS. A VISUAL INSPECTION OF THE DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY (DAQ PCBA) REVEALED NO ANOMALIES. THE RETURNED DAQ PCBA WAS INSTALLED INTO THE FAILURE INVESTIGATION (FI) TEST VENTILATOR IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED. THE FI TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED FAILURE IN THE RETURNED DAQ PCBA. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 11MARCH2019. PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED PROXIMAL PRESSURE SENSOR AUTOZERO FAILED (ERROR CODE 110A) SEEN AT SEVERAL INSTANCES IN THE DEVICE HISTORY REPORT. THE FSE REPLACED TWO OF THE SOLENOID VALVES AND THE DIGITAL TO ANALOG CONVERTER BOARD. THE UNIT WAS READY FOR PATIENT USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS MALFUNCTIONING. THERE WAS NO PATIENT OR USER HARM REPORTED. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199991 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1