BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL FULL FACE NON-VENTED MASK

    MDR report key: 2925621 · Received January 22, 2013

    Report

    Report Number
    9611451-2013-00056
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K083122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ATTEMPTING TO RETRIEVE THE COMPLAINT DEVICES. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT MASKS WERE RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT A VENTED MASK BASE WAS ASSEMBLED INSTEAD OF A NON-VENTED MASK BASE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE INCORRECT ASSEMBLY OF MASK BASE WAS MOST LIKELY DUE TO INCORRECT LINE CLEARANCE DURING PRODUCTION. THE RELEVANT TEAM LEADER HAS BEEN REMINDED TO ENSURE CORRECT LINE CLEARANCE PROCEDURE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT041 MASK STATE THE FOLLOWING WARNINGS: "THIS MASK MAY ONLY BE USED IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF" "VERIFY THAT THE THERAPY DEVICE, I.E. VENTILATOR, INCLUDING ALARMS AND SAFETY SYSTEMS HAVE BEEN VALIDATED PRIOR TO USE"

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE RT041S HOSPITAL FULL FACE NON-VENTED MASKS CONTAINED THE INCORRECT HOSPITAL FULL FACE VENTED MASK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE RT041S HOSPITAL FULL FACE NON-VENTED MASKS CONTAINED THE INCORRECT HOSPITAL FULL FACE VENTED MASK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29578 HOSPITAL FULL FACE NON-VENTED MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT041S 120629

    Patients

    Seq Age Sex Outcome Treatment
    1