MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600; LIFT, PATIENT, NON-AC-POWERED

Device Problems Component Falling (1105); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the caregivers that after completing a resident transfer to bed, the lift was being moved to docking station.The lift made noise which came from the pod.When the pod was moved from the bed area, the spreader bar suddenly fell to the floor as tape slack rolled out of the pod.No injury reported.

Manufacturer Narrative

On 22nd november 2017, arjohuntleigh received information about an incident related to the maxi sky 600 ceiling lift.The issue occurred in (b)(6) hospital located in (b)(6).Following the complaint's description, the ceiling lift stopped working during transfer of the resident from a chair to a bed.To complete the transfer, the caregivers lifted the bed up and removed the resident safety.When the ceiling lift was moved away from the bed area, the spreader bar suddenly fell on the floor.No injury occurred.Neither medical intervention nor hospitalization was required.The inspection of the involved ceiling lift was performed by the arjohuntleigh representative who found that the lift strap (on which the spreader bar was attached) had exceed it limits and fully unwound from the transmission gear, the handset was not functioning, the gearbox was noisy when running the tape out of the pod, handset, ppp power cable and gearbox were worn.The customer allegations regarding not functioning handset, noise of the pod, sudden fall of the spreader bar because the lifting strap (on which the spreader bar was attached) fully unwound from the transmission gear, have been confirmed.Additionally, the powered spreader bar was found in good condition, however the power cable to the spreader bar was damaged leaving the internal cables exposed.This however is not related to the reported issue.It needs to be emphasized that, the transmission box is responsible for providing up/down movement of the lifting strap by activation of the gear movement.In case of any failure of this part during patient transfer, the device is equipped with a safety feature: automatic emergency brake that would engage and will stop a strap from unexpected unwinding.The fall of the spreader bar will be automatically stopped by the safety feature incorporated into the device.Based on the review of previous complaints, we (arjohuntleigh) were able to conclude that reported situation (unexpected and unstopped unwinding of the ceiling lift strap) is likely to occur only when the mechanical emergency brake (element of the transmission box) is not working correctly.This however could not be confirmed, because the device was not released for further evaluation by the customer.Additionally, we were able to establish, that the maxi sky 600 ceiling lift, which for some reason had been removed from the use in may 2017 and placed into storage, was later refitted on the track by the customer.It is unknown if during removal and then refitting of this lift, any damages (which may contribute to the reported issue) occurred.When reviewing reportable complaints related to maxi sky 600 and similar ceiling lifts registered during last 5 year, we have found a limited number of reportable complaints related to the similar issue.Please note, that to ensure that the equipment remains within its original manufacturing specifications, the inspection of the lift should be performed at recommended intervals.For example, according to instruction for use 001.14150.33 rev.6 the technician is obligated to yearly or after 2500 cycles: - inspect frame parts interlock and hardware for malfunction and make sure there are no parts missing, - inspect gears for wear and lubricate as necessary, - verify that the emergency brake on the drum is turning freely, - verify the emergency brake, - load test with the swl (safe working load) recommended.To sum up, while the incident occurred the device was not being used for transfer the patient.The root cause was impossible to define despite the analysis of all collected information.The lifting strap was fully unwound from the transmission box, so the maxi sky 600 ceiling lift was not up to manufacturer's specification.Complaint decided to be reportable based on the potential of serious injury if the incident would to reoccur.

• Brand Name: MAXI SKY 600
• 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
• MDR Report Key: 7116441
• MDR Text Key: 95390484
• Report Number: 9681684-2017-00099
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Distributor Facility Aware Date: 11/22/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2018
• Date Manufacturer Received: 11/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other