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

Model Number LD10213

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient was being transferred with maxi sky 600 ceiling lift from bed to toilet.The device got stuck in a rail and was not easy to be moved.An assisting caregiver had to pull the lift to move it forward along the rail.At that moment the left leg clip of the sling got loose and the resident fell out onto the floor.As a consequence of the fall he sustained a fracture of the hiphead and a small fracture of his left upper arm.The injury required a surgery and hospitalization.

Manufacturer Narrative

The investigation has been performed and the conclusions are following.It was reported that the caregiver was using arjohuntleigh maxi sky 600 ceiling lift system to transfer the resident from a bed to a toilet.For the transfer non-arjohuntleigh toileting sling (identified as (b)(4)) was used.On the way back from the toilet the system stuck on the rail and a caregiver needed to use a force to push the ceiling lift further in the track rail.The leg clip loosen from the ceiling lift spreader bar and detached from its intended position.As a consequence, the resident slipped out of sling and fell on the floor.The resident sustained hip bone fracture, head injury and small break on the left upper arm.An operation to hip was required where a part of hip bone was removed.After the event, the device was examined by an arjohuntleigh service technician.No damages to arjohuntleigh ceiling lift were detected.From the photographic evidence it could be concluded that the rail track on the connection point was not fitted correctly which made the lift stuck in a half way.After the event, the claimed installation was adjusted by arjohuntleigh technician.Along with arjohuntleigh ceiling lift, the customer was using non-arjohuntleigh sling.Looking at the photographic evidence of the sling label, the last maintenance was performed in 2015.The maxi sky 600 ceiling lift installation was completed on (b)(6) 2015 by an arjohuntleigh technician and the last maintenance was performed on 3rd mar 2017 by arjohuntleigh service technician.No issue has been detected that time.The incident occurred 6 months after the maintenance was completed.We have not found another complaint for this device of similar nature in a corporate handling system.It is unknown why the traversal rail became misaligned.Because non-arjohuntleigh sling was used, we are not in a position to determine the actual root cause of the incident.It is unknown if the clip mechanism was working correctly and if the sling selected was of proper size.The device user manual ((b)(4)) notes: "arjo ceiling lifts are specifically designed for arjo kwiktrak ceiling rail systems, slings and accessories.If slings of any other manufacturer for some reason are used, always make sure these slings are ce- marked and are attended by the manufacturer of the sling to be used on the maxi sky 600." please note, that track misalignment on its own would not cause the patient fall, several other factors need to occurred.In the complaint at hand such additional factors were: non-arjohuntleigh sling, pushing the lift with force, stuck of the lift.In summary, when the event occurred arjohuntleigh ceiling lift was used for the resident's handling and in that way was directly involved in the event.The arjohuntleigh ceiling installation rail failed to meet its performance specification because the traversal rail became misaligned.However, the misalignment of traversal rail on its own would not result in a resident fall, several other factors need to occur.We report this incident because of patient fall and a serious health outcomes.

• Brand Name: MAXI SKY 600
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6933722
• MDR Text Key: 89147531
• Report Number: 9681684-2017-00081
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: LD10213
• 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: 11/07/2017
• Distributor Facility Aware Date: 09/15/2017
• Device Age: 9 YR
• Event Location: Home
• Date Report to Manufacturer: 11/07/2017
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2008
• 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 Age: 15 YR
• Patient Weight: 70