BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTURION

    MDR report key: 1371663 · Received February 11, 2009

    Report

    Report Number
    1824619-2009-00001
    Event Type
    Other
    Date Received
    February 11, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 27, 2009
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    LRP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1824619-012209-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SEALS ON THE BREATHER BAGS MAY BE WEAK DUE TO AN INTERMITTENT MALFUNCTION WITH THE HEAT CONTROL RELAY ON THE SEALER. A VISUAL INSPECTION WAS PERFORMED ALONG WITH A BASIC PHYSICAL EVALUATION OF THE SEAL.

    Description of Event or Problem · 1

    THE KITS MAY POTENTIALLY CONTAIN WEAK SEALS DUE TO AN INTERMITTENT MALFUNCTION WITH THE HEAT CONTROL RELAY ON THE SEALER. TRI-STATE INITIATED A VOLUNTARY RECALL ON JANUARY 15, 2009, APPLICABLE TO PRODUCT MANUFACTURED BETWEEN THE DATES OF 11/07/2008, AND 11/21/2008. UPON NOTIFICATION OF THE RECALL TO THE (B)(4) DISTRICT OFFICE ON 01/14/2009, THE RECALL COORDINATOR SUGGESTED THAT WE LOOK INTO WHETHER WE NEED TO FILE AN MDR. (B)(4) FROM CDRH RETURNED OUR CALL ON 01/27/2009, AND SUGGESTED THAT WE FILE A REPORT BEING THAT THE EVENT COULD "POTENTIALLY LEAD TO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION CUSTOM COVENIENCE KITS LRP TRI-STATE HOSPITAL SUPPLY CORP. CHT505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other