MAUDE Adverse Event Report: ARJO MEB. AB LTD. TEMPO; LIFT, PATIENT, NON-AC-POWERED

Model Number KPA0500

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjo has become aware of the event involving tempo passive floor lift and clip sling, which occurred in (b)(4) facility located in (b)(6).It was reported that during resident transfer from bed to wheelchair, when the resident was being positioned (staff was tilting the hanger bar) from semi-reclined to seated position the left shoulder clip detached.The resident (male, (b)(6) years, (b)(6) kg) was not over the wheelchair while the event occurred and as a consequence he fell out of sling and hit the left leg of the lift.The resident sustained a laceration to the head and some slight bruising on the head and ribs.He was treated with ice pack to back of the head, was given the pain medications and had a heat rub on his neck provided.The inspection of the involved passive floor lift was performed by an arjo representative.The lift was found to be in good working condition (all lift functions operated correctly) with normal signs of age (13 years).There were no claims regarding the sling ((b)(6)-xl) reported, excepting faded label.All clips of sling were checked to attach firmly to the connection points on the lift's hanger bar.During reviewing of the event details arjo representative provided guidance to the facility staff members presenting the importance of ensuring that all 4 clips are attached correctly before proceeding with the transfer.Arjo representative also attempted to recreate the event - he attached the sling to the hanger bar and tried to disengage the clips from it by flipping the sling in an upward motion, without success.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).A sling clip, once correctly attached and monitored to stay in place by caregivers as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It is not likely to come off during on-label use.It cannot go inward because it is stopped by the metal frame of the spreader bar.It cannot go outward because it is stopped by the metal end stop of the clip attachment lug.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.Previous simulations have established this to be at minimum over 13% of the body weight of the patient.During the clip detachment the person is likely to fall away from the sling, toward the corner where the clip is not in place.Following all details reported the patient was lifted from the bed, therefore from the horizontal position.In order to place the patient on the wheelchair, the spreader bar needs to be moved to a seated position and turned into appropriate direction.It was indicated that shoulder clip detached during resident repositioning (tilting the hanger bar).Based on our knowledge, it is possible that clip might detach during the resident transfer when one of the clips is attached incorrectly (unstable position of the clip sling - the lug not locked at the top end of the clip) and the sling or the spreader bar is subjected to movement (during patient repositioning (like in this particular case), resident's movement, sudden jerk, accidental collision with other object, etc.).The caregivers are obligated to check the clip attachment before transfer, as well as during the lifting process (continues check that all clips stay in place is required).The tempo instructions for use (ifu kpx50550 issue 5) warns: "important: always check that the sling attachment clips are fully in position before and during the commencement of the lifting cycle, and in tension as the patient's weight is gradually taken up." the passive clip sling ifu (04.Sc.00 rev.2) also warns: "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during lifting process." what is more, the sling ifu indicates the steps of proper sling attachment and lifting process: "[.] 18.Slightly lift the resident to create tension in the sling.19.Make sure that: all clips are securely attached.All straps are straight (not twisted).The resident lays comfortably in the sling [.]." finally, the labelling for the lift device and sling indicate the system should be used by trained personnel that are aware of the ifu contents.No malfunction with the sling, neither lift that could have caused or contributed to the clip detachment was reported.Based on the product knowledge and simulations, it comes forward that when the labeling is followed and the sling is placed in the correct way and the instructions of using the system are followed, there is no possibility of a patient drop or other adverse event during the transfer of the patient.Review of similar complaints, reported in the past confirmed that this failure is only possible to occur when the labeling is not followed.To conclude, the system - clip sling and passive floor lift was used for patient's care and in that way contributed to the alleged event.No defect has been found within the sling and lift that could cause or contribute to the event, but since the sling clip detached from the spreader bar, it can be stated that the system did not perform as intended.We report this event to competent authorities based on potential for serious injury if the incident would to recur.

Event Description

On (b)(6) 2018 arjo has become aware of the event involving tempo passive floor lift and clip sling, which occurred in (b)(6) facility located in (b)(6).It was reported that during resident transfer from bed to wheelchair, when the resident was being positioned (staff was tilting the hanger bar) from semi-reclined to seated position the left shoulder clip detached.The resident (male, (b)(6) years, (b)(6) kg) was not over the wheelchair while the event occurred and as a consequence he fell out of sling and hit the left leg of the lift.The resident sustained a laceration to the head and some slight bruising on the head and ribs.He was treated with ice pack to back of the head, was given the pain medications and had a heat rub on his neck provided.

• Brand Name: TEMPO
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO MEB. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer (Section G): ARJO MEB. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7554400
• MDR Text Key: 109772604
• Report Number: 3007420694-2018-00117
• 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
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KPA0500
• 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: 05/30/2018
• Distributor Facility Aware Date: 05/07/2018
• Device Age: 13 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/30/2018
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2005
• 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 Age: 73 YR
• Patient Weight: 100