BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NON-REBREATHING MASK W/ SAFETY VENT

    MDR report key: 1881406 · Received October 7, 2010

    Report

    Report Number
    3004365956-2010-00289
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 28, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS SENT TO THE MFG SITE FOR EVAL. THE RESULTS OF THE INVESTIGATION ARE FROM PHOTOS AND TESTING OF STOCK PRODUCT. EVAL: METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: DEVICE HISTORY RECORD REVIEW - LOT NUMBER UNK BUT LOT# 02J1001357 WAS SUBSTITUTED FOR REVIEW. NO ISSUES WERE FOUND IN THE REVIEW. PULL AND HEAT TESTING DONE AND COMPARED TO PHOTOS PROVIDED BY CUSTOMER. SOME SIMILAR CONDITION WAS OBSERVED WHEN COMPARED TO THE PHOTOS. RESULTS: THE GREEN TAPE USED TO HOLD THE BREATHING BAG IS SHORTER THAN USUAL. CONCLUSIONS - COMPLAINT CONFIRMED. ROOT CAUSES: HEAT, FLOW AND GREEN TAPE LENGTH. THE MFG TEAM MODIFIED THE SET-UP PROCEDURE USED TO SET THE LENGTH OF THE GREEN TAPE DISPENSER. ALSO, A VISUAL HELP WITH THE LENGTH WILL BE CREATED AND THIS WILL BE USED TO ADJUST THE GREEN TAPE DISPENSE GREEN TAPE LENGTH WILL BE CREATED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE RESERVOIR BAG CAME OFF AFTER LESS THAN 24 HOURS OF USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NON-REBREATHING MASK W/ SAFETY VENT NON-REBREATHING MASK CBP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1