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

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2018 arjo representative has been informed about complaint with involvement maxi move lift.During patient transfer the sling had detached at one or both of the foot end.There is no information if the resident had slid or fallen to the floor (or if there were any injuries).Facility also stated that they had quarantined the sling.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

On 04/04/2018 arjo has become aware of the event with the involvement of patient handling system: maxi move passive lift and sling which occurred in colonel robert l howard state veteran home located in pell city, al, usa.The arjo service technician was dispatched to the customer facility to perform service maintenance and repair, as per customer request.Upon service technician visit, he was informed about the incident.It was reported that during patient transfer, the sling clip detached.Further information regarding circumstances of the event or confirmation if patient sustained an injury was not disclosed by the facility to date.As part of the service, the functional and visual inspection was carried out.The device functional test showed that the mast became lose and the lowering pin was missing.The sling inspection showed that label and stiffeners were missing.The photography evidence that was provided with a complaint showed that sling with black clips was used at the time when the event occurred.The clip sling was not cracked or broken.Despite our best efforts and many attempts to contact the customer, the facility did not reveal any additional information related to the event.In this regards, we end up with some questions unanswered.Review of reportable events registered during last 5 years shows that there have been found complaints with a similar fault description (clip detachment).Product's instruction for use (ifu) is provided with each device.Ifu 04.Sc.00-int1_2 dated october 2014 provides guidelines for agitated patients.It indicates that - "at any time, if the resident becomes agitated, stop transferring/transporting and safely lower the resident." -"to avoid injury, always assess the resident prior to use." - "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process." based on the product knowledge and a technical simulation conducted in the past , it comes forward that when the labeling is followed and the sling is placed in the correct way and the instructions of using the system is followed, there is no possibility of a patient drop or other adverse event during the transfer of the patient with the sling and lift.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labeling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.Review of similar complaints, reported in the past confirmed that this failure is only possible to occur when the labeling is not followed.To conclude, the system - clip sling and lift was used for patient's care and in that way contributed to the alleged event.The device evaluation showed that sling has missing label and stiffeners.Since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.Due to the lack of sufficient information the exact cause of the incident could not be identified with a certainty.We have decided to report this event to competent authorities due to the fact that if the event will re-occurs it might lead to the serious injury as consequence of the event.

Manufacturer Narrative

Collection of information is ongoing.Additional information will be provided upon conclusions of the manufacturer's investigation.

• Brand Name: MAXI MOVE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• MDR Report Key: 7467951
• MDR Text Key: 107339159
• Report Number: 9681684-2018-00035
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2018
• Distributor Facility Aware Date: 04/06/2018
• Date Report to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/06/2018; 04/06/2018
• Supplement Dates FDA Received: 05/25/2018; 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other