BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 7524814 · Received May 18, 2018

    Report

    Report Number
    9611451-2018-00419
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 20, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PS275512 DEVICE MANUFACTURE DATE: LOT : 170425; 170804. QUANTITY: 2; 1. MANUFACTURE DATE: 25-APR-2017; 04-AUG-2017. METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO F&P HEALTHCARE IN (B)(4) FOR INVESTIGATION. THE CHAMBERS WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT ALL THREE MR290 CHAMBERS SUSTAINED CRACKS AROUND THE BASE OF THE CHAMBER DOME. THE CRACKS WERE FOUND BELOW ONE OF THE PORTS. TWO OF THEM HAD CRACKS AT THE BRACKET AREA. RESIDUE AND SMEARED PRINT WERE ALSO OBSERVED AROUND THE CHAMBER DOME OF EACH MR290. CONCLUSION: THE NATURE OF THE CRACKING AND THE SMEARED PRINT SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE SUBJECT MR290V CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. MOREOVER, THE HEALTHCARE FACILITY REPORTED THAT THE CRACKS OCCURRED IMMEDIATELY AFTER USE, WHICH SUGGESTS THAT THE SUBJECT MR290 CHAMBERS BECAME DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED TO A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED IMMEDIATELY AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370431 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 170425 AND 170804

    Patients

    Seq Age Sex Outcome Treatment
    1