BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 5679690 · Received May 25, 2016

    Report

    Report Number
    9611451-2016-00232
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 25, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES WERE RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). WE ARE OBTAINING FURTHER INFORMATION TO DETERMINE IF FPH'S PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT # & DEVICE MANUFACTURE DATE: LOT # 150916, MANUFACTURE DATE: 09/16/2015, QUANTITY AFFECTED: 2; LOT 50908, MANUFACTURE DATE: 09/08/2015, QUANTITY AFFECTED 1. MANUFACTURER NARRATIVE METHOD: THE THREE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ALL RETURNED MR290 CHAMBERS WERE CRACKED. FURTHER INSPECTION SHOWED THAT EACH CHAMBER DOME WAS CRACKED ALONG THE BASE, STARTING EITHER BELOW THE PORT OR BETWEEN THE PORT AND THE HINGE BRACKET. RESIDUE AND SMEARED PRINTS WERE ALSO OBSERVED IN SEVERAL PLACES ON THE OUTER SURFACE OF THE CHAMBER DOMES. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 150916 BUT NONE FOR LOT NUMBER 150908. CONCLUSION: THE NATURE OF THE CRACKING, RESIDUE AND SMEARED PRINTS 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 DOMES. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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. 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." - "MAXIMUM OPERATING PRESSURE: 8 KPA."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS FROM WERE CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335257 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1