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

Model Number KMCLUN-D

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 12/24/2023

Event Type  Injury  

Manufacturer Narrative

Following the information reported, the event occurred with the participation of maxi move passive floor lift and toilet, clip sling.The patient fell out of the sling backward and hit his head on the floor.As a consequence sustained the subdural hemorrhage.This event occurred at the beginning of the patient's transfer from the wheelchair to the bed.The sling and floor lift evaluation did not reveal any failure that could contribute to the reported event.The review of complaints and all gathered information allowed to determine the most probable scenario of the patient slipping out of the sling.As the event occurred at the beginning of the transfer, this may prove that one of the shoulder clips was not attached to the spreader bar before the transfer.The maxi move¿s spreader bar has a ¿mushroom shape¿ at the end of the lug.It does not only make sure that the clip cannot slide off, but also makes sure that the clip is correctly attached.Once the clips are installed and the lifting has begun, the tension present during the transfer maintains a downward force on the clips ensuring they remain in the desired location on the lugs.The instructions for use (ifu, 001.25060.En rev.19) states: "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." " it is essential that the slings (.) and attachment clips are carefully inspected before each and every use." during the interview with the customer, it was also pointed out by the director of nursing that the transfer was performed by one person, instead of the team.The instructions for use informs: "it is responsibility of each facility or medical professional to determine if a one or two-person transfer is more appropriate, based on the task, resident load, environment, capability, and skill level of the staff members".To sum up, the arjo floor lift and the clip sling were used as a system during the patient transfer.The clip detached from the lift spreader bar and from that perspective system did not meet its performance specification.The complaint decided to be reportable due to the patient slipping out of the sling and serious injury sustained.

Event Description

Following the information reported, the event occurred with the participation of maxi move passive floor lift and toilet, clip sling.The patient fell out of the sling backward and hit his head on the floor.As a consequence sustained the subdural hemorrhage.This event occurred at the beginning of the patient's transfer from the wheelchair to the bed.

• Brand Name: MAXI MOVE
• Type of Device: 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: 18483232
• MDR Text Key: 332548010
• Report Number: 9681684-2024-00002
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 05055982764421
• UDI-Public: (01)05055982764421(11)230427
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KMCLUN-D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG