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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the patient transfer from a shower trolley to the bed the patient slipped out of the sling.It was reported that the caregiver did not use the sling stiffeners during the transfer.The nurse manager from the customer facility stated that the caregivers might not have attached a sling clip to the lift spreader bar.The resident sustained a hematoma and laceration requiring staples.
Additional Manufacturer Narrative
Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
An arjo representative was informed about the event involving maxi move passive floor lift and a sling (mesh sling maa4160m-m).Following information provided a resident was transferred by two caregivers from a hygienic lift to a bed.It was reported that during transfer the resident fell out from a device and hit her head on the ground.As a consequence of the event the resident sustained hematoma and head injury which required six staples.Following information provided the resident had contractures at knees but no behavioral issues were observed by the staff.The resident wasn't agitated or confused during the transfer.The sling legs clips were not crossed, and the sling was applied with a regular attachment procedure.During interview the customer stated that the sling was used with no plastic support stays/stiffeners inside the head section of the sling.The nurse manager from facility suspected that the staff did not attach a sling clip to a lift spreader bar lug.The passive sling clip instruction for use (04.Sc.00) instructs to : ¿check that the stiffeners are completely inside the stiffener pockets if any.¿ following all details reported, it seems that the incorrect sling application led to the resident fall.Additionally, the missing stiffeners in sling head section could additionally influence the resident¿s stability in the sling leading to the fall.To sum up, arjo floor lift and clip sling were used as a system for a resident transfer when the resident fell out of a device.The head stiffeners were missing and from that perspective system did not meet its performance specification.We decided to report this complaint to the competent authorities due to reported resident fall and serious injury occurrence.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17806558
• Report Number: 9681684-2023-00068
• Device Sequence Number: 6727880
• Product Code: FSA
• UDI-Device Identifier: 05055982766951
• UDI-Public: (01)05055982766951(11230130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/25/2023
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 41 KG