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

Model Number KMCLUN-D

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

It was repotted that paten was transfer to the wheelchairs by using maxi move lift and sling it was reported that when customer lowered her husband on the wheelchair and started to remove the sling, the chair feel backwards with patient.It was reported that the wheelchair brakes were not locked.The patient fall and did not sustained any injuries there was no device malfunction found with the device which might led to patient fall.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

Arjo received information about an event involving maxi move lift.A patient was transfer to a wheelchair.It was reported that when the patient was lowered on the wheelchair and a caregiver was attempting to detach the sling from a lift, the patient owned wheelchair fell backwards.As a consequence, the patient fell on the floor, no injury was sustained.The maxi move lift was evaluated by the arjo service technician.The lift was in good functional condition, no technical failure was found, only the guiding pins which are placed inside the spreader bar were bent.They are no related to the reported wheelchair fall.The wife stated that when the event occurred the brakes were not applied on the wheelchair.There was no reports of arjo lift malfunction.To sum up, the arjo floor lift and passive clip sling was used as a system for a patient transfer when the wheelchair fell backwards and resident fell.No arjo device malfunction was found which may lead to the reported complaint.Initially, we decided to report this complaint to the competent authorities in abundance of caution due to the reported patient fall during the transfer.However there is no allegation that the lift contributed to the wheelchair moving backwards and patient fall.

• 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: 13051014
• MDR Text Key: 283149202
• Report Number: 9681684-2021-00062
• Device Sequence Number: 1
• Product Code: FSA
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KMCLUN-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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): Other