BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREEZE PUMP - USA

    MDR report key: 2163442 · Received June 27, 2011

    Report

    Report Number
    1000381138-2011-00006
    Event Type
    Other
    Date Received
    June 27, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED DURING THE FACILITY INVESTIGATION THAT THE MAINS CABLE FROM THE BREEZE PUMP UNIT WAS MOVED FROM ITS ORIGINAL SAFE POSITION AND PLACED THROUGH THE UNDERSIDE OF THE BED FRAME WHERE THERE IS A POTENTIAL FOR CABLE DAMAGE TO OCCUR. OUR CONCLUSION IS WHEN THE SYS WAS INITIALLY INSTALLED, THE CABLE WAS MANAGED (POSITIONED) SO THAT CABLE ENTRAPMENT WAS AVOIDED. DUE TO INCORRECT USER HANDLING, THE PUMP UNITS MAINS CABLE WAS PLACED IN A POSITION WHEREBY INCREASED RISK OF CABLE ENTRAPMENT WAS POSSIBLE AND DID EVENTUALLY OCCUR CAUSING A SPARK AND BURN MARK ON THE FRAME. IN OUR PRODUCT RISK ANALYSIS FILE OUR DETERMINATION WAS: HISTORICAL DATA DEMONSTRATES THAT THIS AND SIMILAR DESIGNS GIVE FEW AND MINOR OCCURRENCES OF HARM. HAVING REVIEWED THE PAST 2 YEARS COMPLAINT EVENTS, WE HAVE NOT RECORDED ANY INSTANCES OF THIS NATURE WITH THE BREEZE SYSTEM, HOWEVER, IT MAY NOW BE NECESSARY TO REVIEW THE "PROBABILITY OF OCCURRENCE" FOR ALL SYS DUE TO THE GENERAL RISK ASSOCIATED TO THIS TYPE OF EVENT FROM SIMILAR SYS. A REVIEW OF IFUS FOR OTHER CURRENT PRODUCTS FINDS THEY ADEQUATELY WARN OUR USERS OF THE RISKS WHEN INSTALLING AND CORRECTLY MANAGING THE MAINS CABLES. WE WILL REVIEW/UPDATE THE IFU CONTENT OF THE BREEZE (AND OTHER PRODUCTS AS APPLICABLE) TO IMPROVE THE WARNING INFO. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE ELECTRICAL MAINS POWER CORD FROM THE BREEZE PUMP UNIT WAS CAUGHT IN THE MECHANICAL MOVING PARTS OF THE BED FRAME (HILL-ROM CENTURY) CAUSING THE CORD TO BE STRIPPED. THIS CUT THROUGH THE WIRES WHICH CAUSED A SPARK AND BURN MARK ON THE FRAME (WHERE IT WAS CUT). THERE WAS NO INJURY TO PT OR USER FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE PUMP - USA ALT PRESSURE AIR FLOTATION MATTRESS FNM ARJOHUNTLEIGH 625303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other