MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2; LIFT, PATIENT, NON-AC-POWERED

Model Number MS110-00-00

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 arjo was informed about the incident, which occurred with participation of the maxi sky 2 ceiling lift.It was reported that the lifting strap stitching failed and the patient fell onto the bed from a height of 1 foot.No injury was reported.

Manufacturer Narrative

On 20-jun-2018 arjo was informed about the incident, which occurred with the involvement of the maxi sky 2 ceiling lift.The incident took place in the (b)(6) hospitals in (b)(6) (uk).It was reported that during transfer of the patient, the strap stitching has failed.As the result, the spreader bar become detached and the patient dropped onto the bed (from a height of 1 foot).During this incident, 3 trained nurses were present.The spreader bar was caught by the caregiver.No injury was reported.The device was withdrawn from use and the engineer from the facility maintenance team was called.The lift was not under the arjo contract, it was serviced by the third- party company.After receiving information regarding the incident, the customer was visited by arjo representative who inspected the maxi sky 2 ceiling lift.During evaluation of the involved device, it was determined that the lift was in good condition, the strap was replaced by the engineer from the third-party company.The conducted analysis showed that the defective strap had discolored threats.The involved maxi sky 2 lift was manufactured in august 2014 and the strap was manufactured in june 2014, which can indicate that the defective component was the originally fitted one.Based on the gathered information, it was established that the room where the incident occurred was cleaned using the solution of hydrogen peroxide between 5-6 times per week.Taking into account the age of the strap, it could have a contact with this chemical (hydrogen peroxide) for about 2000- 2400 times.This chemical compound could have contributed to the premature wear of the fabrics.The instruction for use 001-15689- en dedicated to the maxi sky 2 includes information regarding care and maintenance.The maxi sky 2 ceiling lift should be serviced every 12 months.The strap inspection is one of the steps, which should be performed: "if the strap is damaged or shows signs of wear or discoloration, the acceptable load on the strap before rupture can drop rapidly and present a danger for the patient or caregiver." additionally, in accordance with the manufacturer recommendation, the strap should be changed every 2 years or every 5000 cycles.It is probable that the maintenance of the device was not performed by the third-party company in the way described in the instruction for use.It may be indicated by the age of the strap (almost 4 years in use).When reviewing similar reportable events registered in the last 5 years, we have not found any similar complaint related to the investigated issue.According to that, this particular complaint appears to be an isolated one.Sum up, while the incident occurred the device was being used for a patient's transfer.The device was not according to the manufacturer's specification because the lifting strap broke during the transfer.Complaint decided to be reportable based on the potential of serious injury if the incident would to re-occurred: resident's fall during the transfer.

• Brand Name: MAXI SKY 2
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• MDR Report Key: 7663136
• MDR Text Key: 113183992
• Report Number: 9681684-2018-00057
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MS110-00-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2018
• Distributor Facility Aware Date: 06/20/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 104