BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANACEA 7000

    MDR report key: 883342 · Received July 16, 2007

    Report

    Report Number
    1931947-2007-00002
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 13, 2007
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION IS ALLEGED. THE INITIAL REPORTER (FACILITY ADMINISTRATOR) REPORTED THAT THE STAFF HAD NO COMPLAINTS WITH THE BED. THE FACILITY STAFF WAS ESPECIALLY PLEASED WITH THE PERFORMANCE OF THE MATTRESS KEEPERS - PARTICULARLY BECAUSE THE RESIDENT SUFFERED FROM EXTREME INVOLUNTARY MOVEMENTS. PER THE INITIAL REPORTER THE HEAD BOARD WAS EASILY REMOVED TO FREE THE PATIENT. THE MATTRESS INVOLVED WAS A PANACEA TENDER PLUS DISTRIBUTED BY DIRECT SUPPLY. THE FACILITY MEASURED THE GAP BETWEEN THE HEAD BOARD AND THE MATTRESS AS ONE AND FIVE EIGHTS INCHES. THIS GAP SIZE IS EXACTLY WHAT NOA WOULD EXPECT TO FIND WITH A SIMILAR, PROPERLY SIZED, MATTRESS. NOA HAS NOT REQUESTED THE BED TO BE RETURNED FOR EVALUATION AS THERE IS EXACT CORRELATION BETWEEN THE FACILITY AND NOA. THE CURRENT FDA/HBSW GUIDANCE, ISSUED 03/10/2006 DOES NOT OFFER ANY DIMENSIONAL GUIDANCE FOR ZONE 7. THE DRAFT OF THE SAME GUIDANCE DOCUMENT, ISSUED 08/30/2004 INDICATED THE GAP SHOULD BE LESS THAN FOUR AND THREE QUARTERS INCHES. THE ACTUAL ZONE 7 GAP OF ONE AND FIVE EIGHTS INCHES IS SIGNIFICANTLY SMALLER THAN THE DIMENSIONS OF ANY BODY PART LISTED IN THE GUIDANCE DOCUMENT. THERE IS NO CORRECTIVE OR REMEDIAL ACTION ANTICIPATED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT'S HEAD ALLEGEDLY BECAME STUCK BETWEEN THE HEAD BOARD AND THE MATTRESS (ZONE 7 ENTRAPMENT). THE DIXON FIRE DEPARTMENT RESPONDED AND FREED THE PATIENT. THE HEAD BOARD WAS EASILY REMOVED ACCORDING TO THE INITIAL REPORTER. THERE WAS NO ACTUAL SERIOUS INJURY. THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANACEA 7000 AC ELECTRIC HOSPITAL BED FNL NOA MEDICAL INDUSTRIES, INC. PANACEA 7000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening PANACEA TENDER PLUS MATTRESS