MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI MOVE; LIFT, PATIENT, NON-AC-POWERED

Model Number	KMCSUN-D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	05/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to arjo representative that there was an incident with the involvement of maxi move passive floor lift and passive clip sling.It was reported that during transfer of the resident from the bed to the wheelchair, right shoulder sling's clip detached from the spreader bar attachment point.Following information provided, the patient fell out of the sling to the floor and sustained head injury.Hospitalization was also required and 8 stitches were applied.The resident returned to the facility the same day.
Additional Manufacturer Narrative
Please note that patient code was added to the section f of this report.
Event or Problem Description
It was reported to arjo by the nursing home ¿extendicare¿ located in (b)(6), canada that there was an incident with the involvement of maxi move passive floor lift and passive clip sling.The facility administrator stated that the resident fell out of the sling.Following information collected, during transfer from the bed to the wheelchair, the right shoulder sling's clip detached from the spreader bar attachment point.As the consequence of the event the patient sustained head injury.Hospitalization was required and 8 stitches were applied.The resident returned to the facility the same day.

• Brand Name: MAXI MOVE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• MDR Report Key: 10050448
• Report Number: 1419652-2020-00021
• Device Sequence Number: 947668
• Product Code: FSA
• UDI-Device Identifier: 05055982766951
• UDI-Public: (01)05055982766951(11)190919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020
• Report Date (Section F): 06/09/2020

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?: No
• Operator of Device: Other
• Device Model Number: KMCSUN-D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2020
• Device Age: 8 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50
• Date Report Sent to FDA: 06/09/2020