MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI MOVE; FSA

Model Number KMCSAN

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problems Bruise/Contusion (1754); Fall (1848); Bone Fracture(s) (1870)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016 (b)(4) received a customer complaint where it was indicated that the resident was transferred from bed into the bath tub using maxi move lift and the sling.The sling was removed from the lifter and the resident remained in the tub for 30minutes.Afterwards the sling was attached to the spreader of the lift and the resident was in sitting position moved out of the bathroom.In this moment the clip from the right shoulder part of the sling came apart and the resident fell on the floor hitting his head on the chassis of the lifter.As a consequence of the event the resident sustained bruise at the skull and upper leg fracture.It was reported that the resident was hospitalized.Treatment was described as "operation".According caregiver the sling was checked before use.

Manufacturer Narrative

An investigation was carried out into this complaint.Based on the information received during the resident transfer from the bath the right shoulder clip from the right shoulder part of the sling came apart due to stitches failure and the resident fell on the lift chassis.Review of reportable complaints for maxi move lift showed that there are no similar events related to strap stitching failure in the sling.Therefore, the incident described above seems to be an isolated event to date.It can be established that the lift and the sling, which work together as a system, were being used for patient care when the event took place, and as such it appears the played a role in the event outcome.There is no indications that part of the lift device failed or otherwise contributed in a way that is found significant for this investigation.Therefore, the investigation will focus on the sling accessory.An on site inspection found the sling with removed label and in poor condition "left clip attachments torn.Open seams.Product label is missing!".These failures were confirmed as the sling has been returned to arjohuntleigh for further evaluation.Additionally, the clips of the sling were found to be dated on march 2009.Therefore, the sling is about 7 years old.According to the maxi move instruction for use (ifu) supplied with the lift: - "the expected operational life for fabric slings and fabric stretchers is approximately two years from date of purchase".Therefore this sling was significantly past its lifetime, it should have been discarded and should not have been used, for many years.Within the scope of a manufacturer investigation, we could stop here, as this device clearly was used beyond its intended and labelled lifetime.However, it was decided to provide additional pull tests for the returned sling trying to check condition of the stitches.As both shoulder straps were damaged, the leg straps underwent pull tests to see what force is needed to damage stitches in the sling.Following the results, we were not able to recreate stitches failure as at first the sling fabric started to rip.For both leg straps the weight put on strap was on average about (b)(6) before the fabric started to rip.Stitches at both leg straps were found to be in good condition.No anomalies were found.Please note that the slings have long series of stitching connecting the clip to the main body of the sling.During normal and on label use, without any malfunction, it is highly unlikely that the strap of a sling will ripped from the main body of sling.This is shown by the lack of complaints volume of such issue when compared to the amount of sold devices and in comparison to their daily use.For the sling to have torn at stitches, we strongly believe it to having been damaged before the transfer.Based on the information received, it appears most likely that both shoulder straps stitches had been damaged before the incident occurred and the sling was used in that condition continuously and off label.The maxi move instruction for use (ifu) supplied with the lift contains crucial information: - "it is essential that the slings, slings loops, straps and attachment clips are carefully inspected before each and every use.If the sling, loops or straps are frayed or the clips damaged, the sling must not be used and should be replaced immediately" from the information available and our evaluation conducted we have come to find it most likely that the event was caused by use error : not following the instructions for use section.We find it likely that the stitches at strap ripped due to excessively exceeding its lifetime.Please note that the customer was visited and interviewed by a local arjohuntleigh representative but could not provide any training dates for staff.Therefore, arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to proper slings inspection before use.This is to be communicated to the customer.

• Brand Name: MAXI MOVE
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5611476
• MDR Text Key: 43765628
• Report Number: 9681684-2016-00017
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/21/2016,04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCSAN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2016
• Distributor Facility Aware Date: 04/14/2016
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/27/2016
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2009
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 110