MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ALENTI; LIFT, PATIENT, NON-AC-POWERED

Model Number CDB8053-01

Device Problems Detachment Of Device Component (1104); Device Tipped Over (2589)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh received information related to alenti hygiene chair.It was reported that after bathing procedure, while the resident was being removed from the tub, one of the alenti castors fell off.As a result, the lift tip over with the resident, causing the resident to fall backwards to the floor.No injuries to resident were reported.

Manufacturer Narrative

An investigation was carried out into this complaint.Arjohuntleigh received information about incident that occurred in (b)(6).It was reported that after the bathing procedure, when the resident was being pulled out of bathtub on an alenti bath chair, one of the wheels fell off, causing the lift to tip over resulting in the resident falling onto his back on the floor.Fortunately, no injury was sustained as a result.After the incident, the device was examined by arjohuntleigh representative.The condition of the device was assessed as good.Although the wheels were found in excellent rolling shape, they were loosely assembled and could pose the risk of re-occurrence of the incident.Both castors have been tightened and alenti was put back into use.Based on our product knowledge, symptom reported: unscrewed castor, is unlikely to occur by itself.It is: likely to take a place when a sequence of multiple use errors occur (with amongst them at a minimum) - blocked castor by hair and debris causing them to stop swirling over a long period of time while still being used, causing the loctite bond to be breached and turned loose.Degenerated loctite after a long period of time.Loosen castors, for example by mechanical impacts which are degenerating loctite connection, when loctite is not playing its role per severe impacts this cause progressive unscrewing of the castor screw.It was established that alenti which took a part in this incident was manufactured in september 2005.According to the operating and product care instructions (opci, document number 04.Cd.02/8gb dated on june 2004), which is delivered with every device: "the useful life of this equipment, unless otherwise stated, is ten (10) years, subject to preventive maintenance being carried out in accordance with the instructions for care and maintenance." it can be stated that this device has reached its operational expected lifetime in september 2015, which was 1,5 years before the incident.Therefore, it is possible that additional factor of loosening the castor could be normal wear of the device, even if no indication of excessive dirt was noted.Lack of the preventive maintenance.Preventive maintenance performed incorrectly.Despite fact that the device was checked on a timely manner, these theories appear possible with the explanation presented below.According to available documentation, the technician performed safety audit and preventive maintenance on october 2016 (3 months before incident).According to the maintenance and repair manual (mrm, document number 09.Cd.03_7gb dated on january 2015), castors check shall include validation concerning wear, movement of every swivel/ wheel and appearance.Moreover: "the decision must be made by the service technician as to the replacement of the castors.When replacement is not carried out the technician must state in the service notes that the castors will remain safe until the next scheduled service." also the replacement instructions are included in the mrm; when replacing castors, threadlocker loctite shall be used and the bolt should be tightened with a proper torque value.What is more, the product owner is obligated to keep the device in a good working order.According to the operating and product care instructions (opci, document number 04.Cd.02/8gb dated on june 2004) give clear guidelines determining caregiver's obligation to maintain alenti on a regular basis."customer obligations shall be carried out by qualified personnel following the instructions in this manual.[.] every week: check that the wheels are properly fixed and are rolling and swiveling freely.Clean with water.(the function can be affected by soap, hair, dust and chemicals from floor cleaning)." in this particular case, the device castors were not properly assembled.From that perspective, it appears the device was not up to specification at the time of the incident.It can be suggested that this castors malfunction was observable to the caregiver prior to this unfortunate event.To sum up, we cannot present a root cause with certainty.A possible root cause for this complaint would be service technician's error - not following the service procedures indicated in the maintenance and repair manual or/and user error - neglecting maintenance procedures indicated in the operating and product care instructions.Additionally, the age of device and its normal wear could be considered as additional contributing factors here.According to the available information, we assess that while the event occurred the device was used for treatment of a person, and therefore it played a role in the event.As per initial information obtained, no serious injury occurred.Our above evaluation shows that alleged resident's fall is not a result if using our device by itself but a result of performing incorrect handling procedures and not following the instructions.

• Brand Name: ALENTI
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6430908
• MDR Text Key: 70903703
• Report Number: 3007420694-2017-00066
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: CDB8053-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2017
• Distributor Facility Aware Date: 02/27/2017
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/26/2017
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 104