BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10007738 · Received April 28, 2020

    Report

    Report Number
    2031642-2020-01582
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Report Date
    April 10, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 09JUL2020 B4: (B)(6)2020. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED PATIENT OR USER HARM. THE CUSTOMER REFUSED THE SERVICE QUOTE. NO REPAIR SERVICE WAS PERFORMED. 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: 28APR2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BUILT-IN ACCUMULATOR BATTERY IS OUT OF ORDER, "ALARM LIGHT EMITTING DIODE (LED) FAILURE. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE AND INDICATED EITHER THE LED IS ON AND THE VOLTAGE SIGNAL FROM THE POWER MANAGEMENT CONTROLLER IS LESS THAN 1.0 VOLTAGE (V) OR GREATER THAN 2.5 V OR THE LED IS OFF AND THE VOLTAGE IS GREATER THAN OR EQUAL TO 0.5 V. THE SERVICE TECHNICIAN PROVIDED REPAIR RECOMMENDATIONS PER THE SERVICE MANUAL: 1. REPLACE THE POWER SWITCH OVERLAY. 2. REPLACE THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) (PM PCBA ONLY IF LED IS FUNCTIONING). 3. REPLACE THE USER INTERFACE (UI) PCBA. 4. REPLACE THE UI TO PM PCBA CABLE. IT IS UNKNOWN IF THE DEVICE DID HAVE PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, HOWEVER, THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471746 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1