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

Model Number	KMCLXN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Arjo was notified about an event involving arjo maxi move passive floor lift and passive clip sling (model no maa4000m-l, serial number (b)(4)).It was reported that during patient transfer from a bedside toilet to a bed, the clip detached from a spreader bar attachment point (lug).Following information provided by the customer the sling clip detached when patient, (who has cerebral palsy) was moving a lot and her arm hit the clip.As a consequence of the event patient fell out from the sling and hit her head on the chassis leg of the lift.The patient sustained a small bump on the head, injury was assessed as not serious.After the incident arjo technician evaluated the lift and sling involved in the event.The inspection did not show any device or sling malfunction.The maxi move instruction for use warns the users to check the sling prior to use and make sure that the sling clips are attached securely before and during the lifting process: ¿caution: always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient¿s weight is gradually taken up.The instruction for use for sling clip contains warning: ¿warning: to avoid injuries, if the patient is agitated, the attendant should wait until the patient calms down before attempting to weigh." to sum up, arjo passive floor lift and clip sling were used as a system for a patient transfer when clip detached and from that perspective system did not meet its performance specification.We decided to report this complaint to the competent authorities due to the allegation of the clip detachment during transfer.
Event or Problem Description
Arjo was notified about an event involving arjo maxi move passive floor lift and passive clip sling (model no maa4000m-l, serial number (b)(4)).It was reported that during patient transfer from a bedside toilet to a bed, the clip detached from a spreader bar attachment point (lug).Following information provided by the customer the sling clip detached when patient, (who has cerebral palsy) was moving a lot and her arm hit the clip.As a consequence of the event patient fell out from the sling and hit her head on the chassis leg of the lift.The patient sustained a small bump on the head, injury was assessed as not serious.

• 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: 11789161
• Report Number: 9681684-2021-00024
• Device Sequence Number: 16399190
• Product Code: FSA
• UDI-Device Identifier: 05055982764438
• UDI-Public: (01)05055982764438(11)200220
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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
• Operator of Device: Other
• Device Model Number: KMCLXN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/07/2021
• 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: Other
• Patient Age: 79 YR
• Patient Weight: 53