BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11289275 · Received February 5, 2021

    Report

    Report Number
    2031642-2021-00451
    Event Type
    Injury
    Date Received
    February 5, 2021
    Report Date
    June 28, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    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

    G4:25JAN2021. B4:25FEB2021. H11:G5:K102985. H10: THE UNIT WAS IN CLINICAL USE, AND THERE WAS NO PATIENT HARM. THE CUSTOMER CONFIRMED THERE WAS NO DEVICE SWAP OUT DURING THIS EVENT. THE CUSTOMER REPLACED THE GAS DELIVERY SYSTEM (GDS) TO RESOLVE THE ISSUE. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE. 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

    G4:03MAR2021. B4:07MAR2021. H11:THE CUSTOMER LET THE UNIT RUN FOR A COUPLE OF DAYS, AND THEY COULD NOT FIND THE ISSUE WITH THE UNIT. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE. 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

    GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION ON CLINICAL DETAILS RELEVANT TO THE DESATURATION BUT WERE UNSUCCESSFUL.

    Additional Manufacturer Narrative · 0

    G4: 02APR2021. B4: 07APR2021. INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE UNIT WAS IN CLINICAL USE AND THE PATIENT DESATURATED. THE UNIT WAS SWAPPED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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) 2021. DATE OF REPORT: 05FEB2021.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT SHUT DOWN DURING PATIENT USE AND WONT START BACK UP. THE CUSTOMER CONFIRMED DIAGNOSTIC ERROR CODE "AUX ALARM SUPPLY FAILED" IN THE LOGS. THE CUSTOMER ALSO ADVISED BEING UNABLE TO POWER THE UNIT BACK ON WITH JUST BATTERY OR ALTERNATING CURRENT (AC). THE CUSTOMER OPENED THE UNIT, UNPLUGGED THE 4 WIRE POWER HARNESS, AND UNIT POWERED BACK ON. THE REMOTE SERVICE ENGINEER (RSE) REACHED OUT TO THE SENIOR TECH WHO SUSPECTED THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD (PCB) DUE TO POWER ISSUE. THE UNIT WAS IN CLINICAL USE, AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186501 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.