BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 4025415 · Received August 20, 2014

    Report

    Report Number
    9611451-2014-00723
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 25, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HORIZONTAL CRACK IN THE CHAMBER DOME NEAR THE BASE WHICH STRETCHES BETWEEN THE CHAMBER PORT AND THE HINGE BRACKET. THE END OF THE CRACK UNDERNEATH THE CHAMBER PORT WAS OBSERVED TO HAVE STRESS MARKS. THE PRINT UNDERNEATH THE CHAMBER PORT ON THE OPPOSITE SIDE OF THE CRACK HAS BEEN SCRATCHED OFF. NO SIGNS OF SMEARED PRINTS OR RESIDUE WERE OBSERVED. THE BASE THICKNESS OF THE CHAMBER WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION, WHICH ELIMINATES MANUFACTURING AS A POTENTIAL CAUSE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 140419. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAS CAUSED THE CRACKING. THE MOST COMMON CAUSES OF CRACKING IN MR290 CHAMBERS ARE ENVIRONMENTAL STRESS CRACKING CAUSED BY THE USE OF HARSH CLEANING CHEMICALS, OR STRESSES INDUCED BY USE OF HIGH FREQUENCY VENTILATORS. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER 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 CUSTOMER HAS CONFIRMED THAT THE CHAMBER WAS IN USE BEFORE THE LEAK WAS OBSERVED WHICH INDICATES THAT THE CHAMBER BECAME DAMAGED DURING USE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN AUSTRIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A MR290 AUTOFEED HUMIDIFICATION CHAMBER LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502541 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 140419

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT380 BREATHING CIRCUIT