ALENTI

Report

Report Number: 3007420694-2017-00027
Event Type: Injury
Date Received: February 9, 2017
Date of Event: December 23, 2016
Report Date: February 9, 2017
Manufacturer: ARJO HOSPITAL EQUIPMENT AB
Product Code: FSA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
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). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT AFTER BATHING PROCEDURE, THE CAREGIVER LOOKED AWAY TO GET NECESSARY ITEMS FOR PATIENT CARE, THE RESIDENT LEANED FORWARD AND SUBSEQUENTLY FELL TOGETHER WITH THE CHAIR. THE DEVICE WAS EXAMINED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. AT THE MOMENT OF THE EVENT IT WAS UP TO MANUFACTURER'S SPECIFICATION EXCEPT FROM WORN BACKREST, WHICH WOULD NOT INFLUENCE THE EVENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, A LIMITED NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (ALENTI TIPPING) WERE FOUND. ARJOHUNTLEIGH HAS MANUFACTURED ABOUT 24000 ALENTI BATH CHAIRS, THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE LOW. IT HAS TO BE POINTED THAT THE ALENTI DESIGN IS ATTESTED AND FULFILLS THE REQUIREMENTS OF THE STABILITY AND DOES NOT TIP WITHOUT ANY REASON. WITH REFERENCE TO INTERNAL TESTS AND IN ACCORDANCE TO INTERNATIONAL STANDARDS, THE ALENTI IS CAPABLE OF MAINTAINING EQUILIBRIUM AT ANGLES FAR BEYOND THE MAXIMUM ENVIRONMENT SPECIFICATIONS, AT FULL SWL, AND IN ITS HIGHEST STROKE POSITION. THE TEST WAS CONFIRMED BY TUV IN 2004. THE OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU 04.CD.02/7 US,CA DATED ON APRIL 2004) CLEARLY STATES HOW TO OPERATE THE DEVICE PROPERLY AND GIVES NUMBER OF PRECAUTIONS TO AVOID HAZARDOUS SITUATIONS. "THE EQUIPMENT MUST BE USED IN ACCORDANCE WITH THESE SAFETY INSTRUCTIONS. ANYONE USING THE EQUIPMENT MUST ALSO HAVE READ AND UNDERSTOOD THE INSTRUCTIONS IN THIS MANUAL. [...] WARNING! NEVER LEAVE THE RESIDENT UNATTENDED AT ANY TIME, PARTICULARLY WHEN THE ALENTI IS IN A RAISED POSITION. [...] WARNING! THE SAFETY BELT MUST BE USED AT ALL TIMES TO MAKE SURE THE RESIDENT REMAINS IN AN UPRIGHT POSITION IN THE MIDDLE OF THE SEAT. [...] RESIDENT ASSESSMENT. WE RECOMMEND THAT FACILITIES ESTABLISH REGULAR ASSESSMENT ROUTINES. CAREGIVERS SHOULD ASSESS EACH RESIDENT ACCORDING TO THE FOLLOWING CRITERIA PRIOR TO USE: THE RESIDENT SHOULD BE ACTIVE OR SEMI-ACTIVE (I.E. ABLE TO SIT UPRIGHT UNSUPPORTED ON THE SIDE OF A BED OR TOILET). THE RESIDENT SHOULD UNDERSTAND AND RESPOND TO INSTRUCTIONS TO STAY SEATED IN AN UPRIGHT POSITION. IF A RESIDENT DOES NOT MEET THESE CRITERIA AN ALTERNATIVE LIFT SHOULD BE USED." " TO AVOID THE POSSIBILITY OF INJURY FROM TIPPING OR OTHER MISUSE, ALWAYS ENSURE THAT: IF THERE IS A DRAIN COVER IN THE AREA WHERE THE LIFT IS MANEUVERED, THE DRAIN COVER MUST BE SMOOTH AND SET LEVEL WITH THE FLOOR." FROM THE EVENT DESCRIPTION, AND COMPARING TO ABOVE CITED QUOTES, IT APPEARS THAT MOST LIKELY A NUMBER OF USE ERRORS AND UNFORTUNATE CONDITIONS CONTRIBUTED TO THE EVENT. 1. THE RESIDENT WAS LEFT UNATTENDED FOR THE MOMENT, WHILE THE CAREGIVER WAS COMPLETING NECESSARY ITEMS. 2. THE RESIDENT WHO LEANED FORWARD WAS CLASSIFIED AS "(B)(6)" IN ARJO MOBILITY GALLERY AND MIGHT NOT BE ABLE TO SIT UPRIGHT UNSUPPORTED. 3. ALENTI WAS USED ON AN UNEVEN FLOOR, WHAT CAUSED ONE OF THE CASTOR TO BECOME LODGED IN THE FLOOR DRAIN. THE DEVICE WAS SUPPORTED BY THREE WHEELS WHAT MADE IT UNSTABLE. FROM ABOVE, THE ROOT CAUSE OF THIS EVENT APPEARS TO BE A USER ERROR - NOT FOLLOWING WARNINGS INCLUDED IN THE INSTRUCTION FOR USE CONCERNING PATIENT ASSESSMENT, POSITIONING AND ENVIRONMENT REQUIREMENTS. THIS ALENTI WAS UP TO THE MANUFACTURER'S SPECIFICATION AT THE TIME OF EVENT. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE EVENT. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE SHOWS THAT IF ALL THE WARNINGS AND RECOMMENDATIONS WERE FOLLOWED IN ACCORDANCE TO INSTRUCTION FOR USE, THERE WOULD BE NO PATIENT OR CAREGIVER AT RISK.

Description of Event or Problem · 0

ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT AFTER COMPLETING THE BATH, THE RESIDENT WAS SEATED IN THE ALENTI WITH THE CAREGIVER ABOUT TO PROVIDE PERI-CARE. AS THE CAREGIVERS LOOKED AWAY MOMENTARILY TO GET THE NECESSARY ITEMS, THE RESIDENT STARTED TO MOVE WHILE SEATED IN THE ALENTI. UNFORTUNATELY THE MOMENTUM COULD NOT BE STOPPED AND THE RESIDENT LANDED ON THE FLOOR WITH THE CHAIR ON TOP OF HIM. AS A RESULT OF THIS ADVERSE EVENT, THE RESIDENT SUSTAINED A BROKEN ARM, BRUISED FACE AND KNEES. HE WAS HOSPITALIZED; THE TREATMENT CONSISTED OF CAST FOR THE BROKEN ARM, PAIN MEDICATION, CONSISTENT MONITORING AND NEUROVITALS EVERY HOUR. IT WAS NOTED THAT THE DRAIN WAS INTACT BUT THE LINOLEUM FLOOR WAS RAISED AROUND THE DRAIN WHERE THE ALENTI WAS POSITIONED AT THE TIME. TWO POTENTIAL FACTORS WERE POINTED WHICH CAUSED ALENTI TO TIP OVER: ONE OF THE CASTORS ON THE ALENTI BECAME LODGED AGAINST THE RAISED FLOORING AND DRAIN AND THE RESIDENT WHO STARTED TO MOVE FORWARD HIS MOMENTUM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
102145	ALENTI	LIFT, PATIENT, NON-AC-POWERED	FSA	ARJO HOSPITAL EQUIPMENT AB	CDB8053-01

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Hospitalization