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

Model Number KMBB4HSX2FEU

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/11/2017

Event Type  Injury  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh polska sp.Z.O.O.On behalf of the importer arjohuntleigh, inc.(ahus).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab.As of 2014 that number was de activated due to the site no longer being a manufacturer and 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.On (b)(6) 2017 arjohuntleigh received a customer complaint indicating that during of patient transfer from bed to chair with passive lift maxi move and sling, a right leg clip detached from a lift spreader bar and resident fell on the floor.It was informed by the facility, that as a consequence, the resident sustained a bruising on the head and a wound required stitching.When reviewing reportable complaints on maxi move registered during last 5 year with similar fault description (clip detachment), we have found a limited number of reportable complaints.The occurrence rate observed for this failure mode is currently considered to be low.The lift and sling device was inspected by arjohuntleigh representative.The scratches on lift legs, damaged cover on the jib and problem with handset connection were observed.The sling label was unreadable.However, no malfunctions regarding lift and sling were reported which could have caused or contributed to the event.Passive clip sling is a product intended for assisted transfer of residents with limited ability to move.Passive clip sling should be used together with arjohuntleigh lift devices.Product's instruction for use (ifu) is provided with each device.Before every use, ifu (04.Sc.00 int1_2) describes the methods of use.The equipment shall be assessed against, inter alia, damage clip.Ifu provides also written and pictographic guidance regarding proper clip attachment process: "attach the clips (5 steps) 1.Place the clip on the spreader bar lug.2.Pull the strap down.3.Make sure the lug is locked at the top end of the clip.4.Make sure the strap is not squeezed in between the clip and the spreader bar.5.Make sure the straps are not twisted." the document guides, step by step, through a proper sling application.It is important to make sure that the clip sling is attached securely before and during lifting process.According to the instruction for use for maxi move lift: - "always check that all the sling attachment clips are fully in position before and during of commencement of the lifting cycle, and in tension as the patient's weight is gradually taken up." based on the product knowledge and a simulation, 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 is followed, there is no possibility of a patient drop or other adverse event during the transfer of the patient with the sling and lift.A sling clip, once correctly attached and monitored to stay in place 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 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.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 lift, was used for patient's care and in that way contributed to the alleged event.No defect has been found within the clip, but since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.We report this event to competent authorities as serious injury occurred.

Event Description

On (b)(6) 2017 arjohuntleigh received a customer complaint where it was reported that during the resident transfer from bed to chair, with passive lift maxi move and sling, a right leg clip detached from a lift spreader bar and resident fell on the floor.It was informed by the facility, that as a consequence, the resident sustained a bruising on the head and a wound required stitching.

• Brand Name: MAXI MOVE
• 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, 62052 ; PL 62052
• MDR Report Key: 7078413
• MDR Text Key: 93568236
• Report Number: 3007420694-2017-00221
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMBB4HSX2FEU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2017
• Distributor Facility Aware Date: 11/13/2017
• Device Age: 11 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/04/2017
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 80