BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6929102 · Received October 9, 2017

    Report

    Report Number
    2031642-2017-03226
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Report Date
    September 13, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CPU PRINTED CIRCUIT BOARD (PCB) ASSEMBLY WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE OR CONTAMINATION. THE MANUFACTURER'S TECHNICIAN CONFIRMED THAT THE PCB ASSEMBLY WOULD NOT POWER ON A TEST VENTILATOR AND DELIVER BREATHS, AND ALARMED AUDIBLY AND VIA ALARM LEDS. TAPPING ON THE AREA AROUND THE U53 WAS PERFORMED IN AN ATTEMPT TO ACTIVATE THE CLOCK, BUT DID NOT SUCCEED. THE 12 MHZ CLOCK U53 WAS MONITORED WHILE APPLYING HEAT, THEN FREEZE SPRAY - WHEN HEAT WAS APPLIED, THE CLOCK ACTIVATED WITH AN OUTPUT OF 12.01 MHZ AND THE TEST VENT BOOTED UP WITH NO OTHER FAILURES PRESENT. WHEN THE FREEZE SPRAY WAS APPLIED, THE CLOCK STOPPED WORKING WITH AN OUTPUT OF APPROXIMATELY 3.00 HZ AND THE TEST VENT WOULD NOT BOOT UP. THIS FAILURE WAS TRACED TO THE 12.00 MHZ CLOCK AT U53 (LOT CODE: PDI 1010 C), WHICH WAS FOUND TO BE FAILING INTERMITTENTLY. THE U53 WAS REMOVED AND REPLACED AND THE CPU PCB ASSEMBLY WAS REINSTALLED INTO THE TEST UNIT. THE TEST VENT THEN WAS OBSERVED TO BOOT UP SUCCESSFULLY, DID NOT GENERATE ANY DIAGNOSTIC CODES, THE 12 MHZ CLOCK OUTPUT WAS 12.02 MHZ, AND CYCLING THE POWER ON AND OFF DID NOT GENERATE ANY ERRORS. APPLYING HEAT AND FREEZE SPRAY DID NOT CAUSE THE CLOCK U53 TO FAIL. RUNNING A CONTINUOUS OPERATION TEST OF TWO HOURS DID NOT GENERATE ANY ERRORS, AND THE TEST VENT BOOTED UP AND DELIVERED BREATHS APPROPRIATELY. REPLACEMENT OF U53 (LOT CODE: PDI 1010 C) CORRECTED THE FAILURE WITH THIS CUSTOMER RETURNED CPU PCBA.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE UNIT IS POWERED ON THE SCREEN IS BLANK, THE BACKUP ALARM SOUNDS, THE ALARM LED FLASHES. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708020 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1