BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 6489321 · Received April 13, 2017

    Report

    Report Number
    3007420694-2017-00082
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 13, 2017
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED INFORMATION ABOUT AN INCIDENT THAT OCCURRED IN THE (B)(6) IN UNITED KINGDOM. IT WAS REPORTED THAT AFTER BATHING PROCEDURE, THE RESIDENT WAS BEING DRIED BY A CAREGIVERS WHILE SITTING ON ALENTI HYGIENIC CHAIR. FOLLOWING THE INFORMATION REPORTED AT THE TIME OF THE INCIDENT, THE NURSES WHO WAS ASSISTING THE RESIDENT "TURNED AROUND TO LOOK AT SOMETHING AND WHILE DOING SO THE CHAIR TIPPED FORWARD" WITH THE PATIENT STILL SEATED. AS A RESULT, THE RESIDENT SUSTAINED BRUISES TO HIS KNUCKLES. THE SAFETY BELT WAS NOT BEING USED DURING THE INCIDENT. THE RESIDENT WAS ASSESSED AS MOBILE, WITH NO WEAKNESSES, SELF-CARING IN ACTIVITIES OF DAILY LIVING. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A LOW NUMBER OF CASES THAT MAY RELATE TO THE ISSUE INVESTIGATED HERE: ALENTI TIPPING DURING USE. WE HAVE BEEN ABLE TO ESTABLISH THAT COMPARED TO THE AMOUNT OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE, THE OCCURRENCE RATE OF REPORTABLE COMPLAINTS WITH THIS FAILURE IS LOW. THE DEVICE WAS EXAMINED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. THE CONDITION OF THE DEVICE WAS ASSESSED AS EXCELLENT AND THE FUNCTION TEST PERFORMED DID NOT REVEAL ANY TECHNICAL DEFICIENCY. THE DEVICE WHICH WAS USED AT THE TIME OF THE INCIDENT WAS IDENTIFIED AS ALENTI HYGIENIC LIFT, WITH MODEL NUMBER CDB8002-01 AND SERIAL NUMBER (B)(6). IT WAS OVER 14 YEARS OLD AT THE TIME OF THE INCIDENT. THE OPERATING AND DAILY MAINTENANCE INSTRUCTION (IFU, VERSION ACTIVE AT THE TIME OF THE DISTRIBUTION OF THE INVOLVED ALENTI 04.CD.02/2 US FROM JUNE 1998) WARNS AND INFORMS HOW TO USE THE DEVICE CORRECTLY. IT INCLUDES ALSO INSTRUCTION HOW TO PERFORM A RESIDENT'S TRANSFER TO AND FROM THE BATH: "ALWAYS ENSURE THAT THE EQUIPMENT IS USED BY TRAINED STAFF." "THIS EQUIPMENT IS INTENDED FOR LIFTING AND TRANSPORTATION OF HOSPITAL OR NURSING HOME RESIDENTS TO AND FROM HYGIENE ROOMS UNDER THE SUPERVISION OF TRAINED NURSING STAFF AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN ARJO'S OPERATING AND DAILY MAINTENANCE INSTRUCTIONS." IN REFERENCE TO THE INFORMATION DISCLOSED BY THE CUSTOMER FACILITY REPRESENTATIVE, THE FOLLOWING FACTORS WERE FOUND TO BE RELEVANT: 1. WRONG POSITIONING OF THE PATIENT, INCLUDING: SITTING IN A WRONG DIRECTION (BACK TO THE COLUMN INSTEAD OF SIDEWAYS TO THE COLUMN), REACHING SOMETHING IN THE SURROUNDING, LEANING FORWARDS OR SIDEWAYS. TWO LAST POINTS CANNOT BE EXCLUDED, AS THERE WAS NO WITNESS OF THE MOMENT OF THE FALL - THESE FACTORS ARE CONSIDERED RELEVANT. 2. NOT USING SAFETY BELT SAFETY BELT IS INTENDED TO HELP TO MAINTAIN RIGHT POSITION OF THE PATIENT ON THE SEAT. ACCORDING TO THE IFU, THEY SHOULD BE ATTACHED TO THE SEAT BEFORE PLACING THE PATIENT. BASED ON THE PROVIDED PHOTOS, THE SAFETY BELT WAS NOT ATTACHED TO THE SEAT, WHAT COULD BE THE REASON THAT IT WAS NOT USED DURING THE INCIDENT AND THE RESIDENT WAS FREE TO MOVE AROUND THE SEAT AND POSSIBLY CAUSE THE DEVICE TO TIP - THE FACTOR SEEMS TO BE CONTRIBUTING HERE. 3. NOT ATTENDING THE RESIDENT DURING OPERATING THE ALENTI ACCORDING TO THE IFU: "THIS EQUIPMENT IS INTENDED FOR LIFTING AND TRANSPORTATION OF HOSPITAL OR NURSING HOME RESIDENTS TO AND FROM HYGIENE ROOMS UNDER THE SUPERVISION OF TRAINED NURSING STAFF AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN ARJO'S OPERATING AND DAILY MAINTENANCE INSTRUCTIONS." NOT ATTENDING THE RESIDENT WAS CONFIRMED AND COULD BE CONSIDERED AS NOT FOLLOWING THE LABELLING OF THE DEVICE - THIS FACTOR IS CONSIDERED AS RELEVANT. BASED ON THE ABOVE, THIS MAY POINT TO THE STAFF NOT BEING AWARE ABOUT THE SAFETY INSTRUCTIONS AND RECOMMENDATIONS INCLUDED IN THE DEVICE INSTRUCTION FOR USE, TOGETHER WITH LACK OF CAREFULNESS, WAS A PRIMARY CAUSE OF THE EVENT OCCURRENCE. IF THAT ELEMENT OF USE ERROR WAS NOT IN PLACE, THE EVENT COULD PROBABLY HAVE BEEN PREVENTED. THERE WAS NO TECHNICAL DEFICIENCY WITH THE DEVICE. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT THE ALENTI HYGIENE CHAIR WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE EVENT. THIS COMPLAINT DECIDED TO BE REPORTABLE IN ABUNDANCE OF CAUTION AS THERE IS A POTENTIAL THAT SIMILAR SEQUENCE OF ACTIONS CAN RESULT IN SERIOUS INJURY.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED INFORMATION ABOUT AN INCIDENT RELATED TO ALENTI BATH CHAIR. IT WAS REPORTED THAT AFTER BATHING PROCEDURE, THE RESIDENT WAS BEING DRIED BY A CAREGIVERS WHILE SITTING ON ALENTI HYGIENIC CHAIR. FOLLOWING THE INFORMATION REPORTED AT THE TIME OF THE INCIDENT, THE NURSES WHO WERE ASSISTING THE RESIDENT "TURNED AROUND TO LOOK AT SOMETHING AND WHILE DOING SO THE CHAIR TIPPED FORWARD" WITH THE PATIENT STILL SEATED. AS A RESULT, THE RESIDENT SUSTAINED BRUISES TO HIS KNUCKLES. THE SAFETY BELT WAS NOT BEING USED DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273797 ALENTI LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB CDB8002-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other