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

Model Number LD10000

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer was visited by (b)(6) representative.It was established that the liquid observed by the customer was caused by the (b)(4) years old battery.Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2018 (b)(6) was informed about the incident, which occurred at the customer's home in the (b)(6).The customer reported that a liquid leaked from the maxi sky 600 ceiling lift.The liquid fell on the customer's staff causing a hole in the service user t-shirt and damaged two tv remote controls.No injury was reported.

Manufacturer Narrative

On 06-jun-2018 arjo was informed about the incident, which occurred at the customer's home in the uk.The customer reported the leak (yellow-orange color spillage) from the maxi sky 600 ceiling lift and decided to call arjo.The arjo technician visited the customer on (b)(6) 2018 and performed an inspection of the claimed device.During the evaluation, it was confirmed that the leak comes from the lead-acid battery.When repairing the device, the liquid burnt a hole in the service user t-shirt and damaged two tv remote controls.No injury was reported.The technician replaced the battery and returned this component for the further evaluation.The claimed lift was under the arjo service and maintenance contract.The last service of this device was performed on 25-jan-2016.The evaluation of the returned battery showed that this component was manufactured on 06-sep-2010.Based on the serviced history conducted by the arjo representative, it could be determined that the battery was not the originally fitted one and it was replaced during repair of the device on (b)(6) 2010.It indicates that the battery was almost 8 years in use.The new battery used during repair of the lift is a type of non-spillable.This type of battery makes the possibility for a liquid spill to be much lower than with the lead-acid battery.Additionally, the returned battery was tested by the sales and service unit representative.The battery liquid evaluation was performed using the ph paper.The results showed that the ph of the battery liquid was 2 (acid).Based on the clinical expert opinion, this ph cannot cause any serious injury.In the worst case scenario it may result in the skin irritation if the liquid would be left for a long time.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 the patient's handling.The leak was caused by the defective battery, which was in use for almost 8 years.The device was not according to the manufacturer's specification and the repair of the device was needed.The complaint decided to be reportable as the user has been exposed to the battery acids.

• 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
• MDR Report Key: 7644856
• MDR Text Key: 112859725
• Report Number: 9681684-2018-00054
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: LD10000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2018
• Distributor Facility Aware Date: 06/06/2018
• Device Age: 9 YR
• Event Location: Home
• Date Report to Manufacturer: 07/25/2018
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 87