BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 10980205 · Received December 9, 2020

    Report

    Report Number
    2031642-2020-04462
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Report Date
    November 13, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:08MAR2021, B4:08MAR2021, H11:G5:K102054. 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

    G4:02MAR2021; B4:06MAR2021; H11:G5:K102985. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. 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

    G4:04FEB2021 B4:05FEB2021. A PHILIPS REPRESENTATIVE ADVISED THE CUSTOMER TO REPLACE THE BLOWER MOTOR CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE BLOWER ASSEMBLY. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CUSTOMER RESOLUTION HAVE BEEN UNSUCCESSFUL. IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) 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: 09DEC2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A V60 VENTILATOR WAS MAKING LOUD NOISE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439322 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

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