BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11283078 · Received February 4, 2021

    Report

    Report Number
    2031642-2021-00434
    Event Type
    Injury
    Date Received
    February 4, 2021
    Report Date
    May 5, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Removal / Correction Number
    Z-1622-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4:16FEB2021. B4:19FEB2021. H11:G5:K102985. H10: BASED UPON NEW INFORMATION RECEIVED VIA THE CUSTOMER AND REPORTER, DURING THE EVENT IN QUESTION THE PATIENT EXPERIENCED A SEVERE DESATURATION OF PERIPHERAL OXYGENATION (SPO2) DURING TRANSITION FROM THE SUSPECTED MALFUNCTIONING DEVICE TO A KNOWN WORKING BACKUP UNIT. NO FURTHER HARM WAS REPORTER AFTER SUCCESSFUL INTERVENTION OCCURRED. 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 · 0

    ERROR CODES 1134, 1115, 111B & 1104 AND PROVIDED THE FOLLOWING RESULTS: VISUAL INSPECTION OF THE ASSY, POWER SUPPLY, V8000 REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE TEST VENTILATOR (TN-71754693) POWERED UP FROM AC AND DELIVERED BREATHS. IT TRANSITIONED BETWEEN BATTERY AND AC OPERATION WITHOUT ERRORS OCCURRING WITH THE EXCEPTION OF "RUNNING ON BATTERY" MESSAGE. THE TEST VENTILATOR ALSO DISPLAYED THE AC SYMBOL WHEN RUNNING ON AC AND OPERATED FOR 2 HOURS WITHOUT FAILURES. IT DID NOT GENERATE ANY DIAGNOSTIC CODE ERRORS. THE POWER ON SELF-TEST (POST) WAS EXECUTED 15 TIMES WITHOUT GENERATING ANY FAILURES. THE POWER LED (ON/SHUTDOWN BUTTON) INDICATOR ILLUMINATED AMBER WHEN THE VENTILATOR WAS CONNECTED TO AC AND TURNED OFF AND DOES THE INDICATOR ILLUMINATED GREEN WHEN THE VENTILATOR IS STARTED UP. THE V60 POWER SUPPLY WAS TESTED, AND NO FAILURES WERE IDENTIFIED. THE 1134, 1115, 111B & 1104 ERROR CODES COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 0

    THE INSTITUTIONAL RESPIRATORY THERAPIST CONFIRMED THAT THE HI AND LOVT ALARMS WERE SET AND ON FOR THIS PATIENT. THE ALARMS ARE NEVER OFF BY DEFAULT, AND THEIR INSTITUTION DOES NOT TURN THE ALARMS OFF. THE INSTITUTION'S REPAIR SERVICE PROVIDER INDICATED THAT SERVICE WAS NOT REQUIRED AS THE REPORTED PROBLEM OF UNEXPECTED DEVICE SHUTDOWN OF V60 VENTILATORS CONTAINING POWER MANAGEMENT PCBA P/N1055906 HAS A SOLUTION IN PLACE, WITH FIELD CHANGE ORDER (B)(4) ALREADY IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2021. DATE OF REPORT: 04FEB2021.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS ALARMING AND STOPPED VENTILATING WHILE IN USE. THE DEVICE WAS CLINICAL USE AT THE TIME OF THE EVENT. THE VENTILATOR WAS SWAPPED OUT WITH NO REPORT OF PATIENT HARM. THE DEVICE WAS EVALUATED BY THE CUSTOMER (BIOMED) WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE BIOMED STATED THAT THE DEVICE WOULD NOT POWER OFF AND WAS ALARMING CIRCUIT OCCLUDED, LOW LEAK REBREATHING RISK, AND PRESSURE INLET LINE DISCONNECTED. THE RSE INSTRUCTED THE BIOMED TO DISCONNECT THE BATTERY TO POWER THE UNIT OFF. THE BIOMED REVIEWED THE SIGNIFICANT EVENT LOG AND NOTED ERROR CODES. THE BIOMED CONFIRMED THE POWER MANAGEMENT BOARD PART NUMBER. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS THEN DISPATCHED TO THE CUSTOMER SITE TO PROVIDE ADDITIONAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179333 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN PATIENT CIRCUIT, MASK,AND HUMIDIFIER.