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

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Hematoma (1884)

Event Date 05/30/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4) med.(b)(4) ltd ((b)(4)).As of (b)(6) 2010, that number was de-activated due to the site no longer being a manufacturer and until 2014 complaints related to these products were handled by (b)(6) hospital equipment (b)(4) and any medwatch reports were submitted under (b)(4) from 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

On (b)(6) 2018 (b)(6) was informed about an event which occurred in (b)(6) nursing home and rehabilitation center located in (b)(6), usa.It was reported that during resident (female, (b)(6) years old, (b)(6) lbs) transfer from bed to chair, the clip detached from the hanger bar and the resident fell and hit their head.Facility described that the actively agitated resident caused the leg clip to detach.As a consequence the resident sustained a hematoma to the back of the head and was sent to the emergency room.She returned to the facility the same day, but passed away 2 days later ((b)(6) 2018).Initially, it was not confirmed if the resident death was directly related to the reported injury, the only thing mentioned during conversation with the facility administrator was the resident's age.On (b)(6) 2018 it was clarified, that the death was attributed to the injuries sustained.

Manufacturer Narrative

Collection of information is ongoing.Additional information will be provided upon conclusions of the manufacturer's investigation.

Manufacturer Narrative

On (b)(6) 2018 arjo was informed about an event which occurred in (b)(6) for nursing and rehab facility located in (b)(6).It was reported that during resident (female, (b)(6)) transfer from bed to chair with marisa lift and sling, the clip sling detached from the hanger bar, the resident fell and hit their head.The facility described that the actively agitated resident caused the leg clip to detach.As a consequence the resident sustained a hematoma to the back of the head and was sent to the emergency room.She returned to the facility the same day, but passed away 2 days later ((b)(6) 2018).On 2018-jun-22 it was clarified, that the death was attributed to the injuries sustained.It should be emphasized that resident was (b)(6).Despite our efforts, no other additional data were made available by the customer facility.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.During the clip detachment the person is likely to fall away from the sling, toward the corner where the clip is not in place.Based on received information it is clear that the person was lifted from horizontal position.From simulations, we know that in the situation, when the clip is not attached and under tension with the weight of the person in the sling from the start, a drop will be immediate.If the labelling is followed there can be no issue.The user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.Not even when the sling occupant is in a very particular position where their knee can push up the clip, and there is an intention and strength present to do so, can this lead to clip coming loose.Following all details reported the patient was lifted from the bed, therefore from the horizontal position.Based on the product knowledge, we know that a person can be lifted from a horizontal position with one of the leg clips not in place.However, typically when the patient is at the end of that transfer, put into a more upright, seated position before lowering to a wheelchair, the weight shifts towards the missing clip strap and the person falls out.It should be stressed that it was noticed that resident "was agitated cause the leg clip to detach." every arjo sling and lift is supplied with instructions for use (ifu).It was reported the sling's label was unreadable and the sling was fitted with clips manufactured on 2009.Based on that it can be indicated that the sling was approximately 9 years old.Following the lift ifu (kgx00660 rev.4) : "the expected operational lift for fabric slings is approximately 2 years from date of purchase." this has not impacted on the performance of the sling when using according to the ifu but this is an indication that the sling should have been withdrawn from use and replaced, and also indicates that the ifu was not being followed.The marisa ifu (kgx00660 rev.4) indicates the steps of proper lifting process and also points out: "always check that the sling attachment clips are fully in position before and during the commencement of lifting cycle, and in tension as the patient's weight is gradually taken up." "lift the patient using the handset control, and adjust him/her to a comfortable position for transfer." "warning: it is advisable to familiarise yourself and understand the operation of the various controls and features of the marisa and ensure that any action or check specified is carried out before commencing to lift a patient." it is worth noting that there was no malfunction with the sling, or lift that could have caused or contributed to the clip detachment detected upon inspection.The lift was in use for over 10 years, and the sling label was illegible, due to this information their replacement should be considered.It was reported by the arjo representative that "the combination of the lower position of the jib and the sling that was 2 sizes too large for the resident would not create enough lifting space to clear the bed fully during a transfer." marisa ifu warns: "only use arjo supply slings that are designed to be used with marisa.The sling profiles illustrated (.) will help to identify various arjo sling and fabric stretchers available." "a circular label is fitted to the lifter jib for quick colour for size reference." when reviewing the reportable events for marisa lift, we have found a limited number of cases related to this type of event: clip sling detachment during transfer.In summary, the device was being used at the time of the event and played a role in the reported incident.There was no failure found with the sling, nor the involved floor lift that could have caused or contributed to the resident's fall.We are reporting this event to the competent authority as the adverse event occurred.

• Brand Name: MARISA
• 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: 7636855
• MDR Text Key: 112270264
• Report Number: 3007420694-2018-00129
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• 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: 08/10/2018
• Distributor Facility Aware Date: 06/01/2018
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/10/2018
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 104 YR
• Patient Weight: 43