BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA RESPONSE

    MDR report key: 2607289 · Received May 25, 2012

    Report

    Report Number
    3007420694-2012-00015
    Event Type
    Other
    Date Received
    May 25, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNM
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC., ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). AN MDR REVIEW HAS BEEN PERFORMED. TO DATE, IN THE PREVIOUS 2 YEARS, THE THERAPY AND PREVENTION DIVISION HAVE RECORDED 6 MDR'S OF EVENTS RELATING TO PT FALLS (ACROSS OUR WHOLE PRODUCT PORTFOLIO), HOWEVER, THIS IS THE FIRST EVENT WHEREBY OUR ALPHA RESPONSE SYSTEM WAS BEING USED. WE DO NOT SEE THE USE OF OUR PRODUCT AS THE ROOT CAUSE OR A CONTRIBUTORY FACTOR IN ALL OF THE CASES. IN 2010: 1000381138-2010-00001; 00011; 00008 AND 00012. IN 2011: 3007420694-2011-00001. ON 2012: 3005619970-2012-00001. IN THE EVENT OF A PT FALL ARJOHUNTLEIGH WOULD REGARD THE INCIDENT AS AN ADVERSE EVENT, THEREFORE, THE FIGURES ABOVE REPRESENT AN ACCURATE ACCOUNT OF THE NUMBER OF EVENTS LOGGED. THE FACILITY HAS CONFIRMED THAT AT THE TIME OF THE INCIDENT, THERE WERE NO STAFF WITNESSES; NEITHER DID THEY WITNESS THE METHOD OF HOW THE PT WAS GETTING ON THE MATTRESS. ALTHOUGH WE BELIEVE THE PT'S ACCOUNT ON THE INCIDENT, WE CANNOT POSITIVELY CONFIRM THIS. COVERED BY RA ((B)(4)) SECTIONS 10.1, SEVERITY: 3 (FALL MAY CAUSE INJURY) MAY NEED MEDICAL ATTENTION (NO INJURY FROM THIS ACTUAL EVENT). PROBABILITY OF OCCURRENCE OF HARM: 2 (MOVEMENT OF CELLS SMALL) PROTOCOLS INCLUDE THE USE OF SIDE RAILS. ACCEPTABILITY OF RISK DETERMINED AS: 1 HISTORICAL DATA DEMONSTRATES THAT THIS AND SIMILAR DESIGNS GIVE FEW AND MINOR OCCURRENCES OF HARM. THE BENEFITS BY THE SYSTEM IN TERMS OF PRESSURE RELIEF ARE CONSIDERED TO OUTWEIGH THE RISKS. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE AS TO WHY THE PT FELL FROM THE BED. BASED ON THE INFO SUPPLIED, THE PT'S MOBILITY MAY HAVE CONTRIBUTED TO THE EVENT. ACCORDING TO OUR SSU (SALES & SERVICE UNIT), THE PRODUCT WAS IN GOOD CONDITION AND PERFORMED AS PER INTENDED DESIGN. WE ARE ABLE TO ESTABLISH THAT THERE IS NOT A NOTABLE TREND WITH THIS PRODUCT AND ISSUE AND WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. WE FIND THIS COMPLAINT TO BE SAFETY RELATED , AND REPORTABLE TO THE COMPETENT AUTHORITIES, HOWEVER, THE DEVICE DID MEET ITS SPECIFICATIONS. OUR MATTRESS SYSTEMS INTENDED USE IS NOT FOR PTS TO 'SIT ON' THE EDGE AND THIS TYPE OF ACTION COULD CAUSE A RISK OF FALLING. IN REGARDS TO THE PT'S OPINION ON HOW COMFORTABLE AND SAFE THE SYSTEM FEELS, WE (ARJOHUNTLEIGH) CONFIRM THAT WE HAVE NO RECORDED ANY SIMILAR ACCOUNTS OF THIS NATURE AND DO NOT SEE THIS ISSUE AS A CONTRIBUTORY FACTOR, BUT WOULD ACCEPT THEIR COMMENTS AND CONTINUE TO MONITOR THIS ISSUE IN THE FUTURE. IN OUR SYSTEM IFU (464900EN_01, PAGE III - SAFETY WARNINGS), IT INFORMS THE USER THAT IT IS THE RESPONSIBILITY OF THE CARE GIVER TO ENSURE THAT THIS PRODUCT IS USED SAFELY AND A CLINICAL ASSESSMENT IS CONDUCTED. IT ALSO RECOMMENDS: WHILST THE PT IS UNATTENDED, SAFETY SIDES SHOULD BE USED BASED ON CLINICAL ASSESSMENT AND IN LINE WITH LOCAL POLICY. LOCAL POLICY FOLLOWS THE GUIDELINES LAID OUT BY THE (B)(4).

    Description of Event or Problem · 1

    A (B)(6), MALE, PT, UPON RETURNING TO BED ROLLED AND KEPT ROLLING SUBSEQUENTLY ROLLING OUT OF BED. PT STATED HE FOUND THE MATTRESS UNCOMFORTABLE AND UNSAFE. THE PT STATED IF HE TURNED OVER IN BED AND WAS NOT DIRECTLY IN THE MIDDLE OF THE MATTRESS HE FELT HE WAS GOING TO TOPPLE OUT. HE FEELS WHEN SITTING ON THE EDGE OF THE MATTRESS, HE WAS ABOUT TO BE TIP OVER. NO STAFF WITNESS WAS AVAILABLE AT THE TIME OF THE INCIDENT. THERE WAS NO WITNESS ON HOW THE PT WAS GETTING ON TO THE MATTRESS. THE PT IS IN THE HOSPITAL RECOVERING FROM A STROKE BUT AT THE TIME OF THE INCIDENT HE WAS FULLY MOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA RESPONSE PAC FNM ARJOHUNTLEIGH POLSKA SP. ZO.O. 465001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other