BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10509999 · Received September 9, 2020

    Report

    Report Number
    2031642-2020-03181
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    August 18, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2020 B4: 01OCT2020 MULTIPLE GOOD FAITH EFFORTS WERE MADE TO OBTAIN INFORMATION REGARDING DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS WITH NO RESPONSE FROM THE REPORTER AND THEREFORE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS LATER OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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) 2020. DATE OF REPORT: 09SEP2020.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS BY THE CUSTOMER (BIOMED) THAT THERE WAS A CHECK VENT ALARM LED WHEN POWERING ON THE UNIT. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT AND THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE WAS EVALUATED BY THE CUSTOMER WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE BIOMED ADVISED 1105 ERROR CODE WAS IN THE SIGNIFICANT EVENT LOGS. THE BIOMED STATED HE WAS NOT SURE IF LED LIGHTS ARE WORKING. THE RSE ADVISED THE BIOMED THAT PER THE SERVICE MANUAL IF LED LIGHTS ARE WORKING IT IS SUSPECTED TO BE AN ISSUE WITH THE PM PCBA. IF THE LED LIGHTS ARE NOT WORKING THEN IT IS SUSPECTED TO BE AN ISSUE WITH THE POWER SWITCH OVERLAY. THE BIOMED STATED HE WAS GOING TO SWAP OUT PM PCB TO SEE IF THAT RESOLVES THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976709 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1