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

Model Number LD10203

Device Problems Detachment Of Device Component (1104); Installation-Related Problem (2965)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption e2012068 (b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2017, arjohuntleigh received the customer complaint indicating that during the transfer of resident using the maxi sky 600 ceiling lift, a loosening of the installation was observed by the customer.The caregiver was able to complete the transfer to the wheelchair without further issues.Neither injury nor harm were reported.No track detachment occurred.The installation was excluded form use until will be repaired.

Manufacturer Narrative

The customer was visited by the (b)(4) representative to perform interview and initial evaluation, the following information were obtained: the maxi sky 600 ceiling lift device was met to its specification, the one of anchor point on which the rail is installed was damaged (the rod was broken at the extremity).The faulty part was returned for evaluation.At this time we are waiting for inspection of this part.The additional information will be provided after evaluation of returned part.

Manufacturer Narrative

On 8th may 2017, arjohuntleigh received a customer complaint indicating that during the transfer of a resident using the maxi sky 600 ceiling lift, a loosening of the track installation was observed by the customer.The caregiver was able to complete the transfer of the resident to the wheelchair without further issues.Neither injury nor harm was reported.No track detachment occurred.The installation was excluded from use to be repaired.Following the incident, the arjohuntleigh field technician performed an inspection of the involved kwiktrack installation.During the system evaluation, it was found that one of anchor points on which the rail is installed was damaged.An anchor and a rod (part of the installation) were broken and did not support the rail at one point - the installation was still supported by another fixation points.No others obvious damages were noticed.It was also confirmed that the installation was made 9 years ago the, by third party company, not arjohuntleigh.No installation nor maintenance records were made available to arjohuntleigh.The faulty components of the ceiling lift installation were returned to arjohuntleigh fur further inspection on 24th july 2017 and next sent to an external laboratory (b)(4).Upon thorough analysis of the broken part, two facts have been assessed: first, following the chemical analysis, the chemical composition of the threaded rod does not meet the requirements of the grades for this steel.Since this component is hardware material, it cannot be determined with certainty if the third party that conducted rail system installation for the facility at the initial time of the commissioning used the approved part from arjohuntleigh or bought this hardware component from an external provider.Secondly, the micro fractographic analysis of the rod breakage made by laboratory (b)(4) indicated that the rod broke due to a tensile stress sustained, typically coming from an overload.At the time of the event, the patient weight was (b)(6) kg, which is adequate for the safe working load of the installation.However, some items remain undetermined, such as if a safe working load test was performed at the time of the installation and each year during preventive maintenance, as recommended in the instruction for use (ifu 001.14150.33.En rev 4): "load test with the swl (maximum working capacity) recommended - every year." some others recommendations are also indicated, which could have permitted to detect the possible failure before the occurrence of breakage: - "make sure the rail is straight when it is not loaded.- every year" - "make sure rail joint are closed and that the spring pin is centered.- every year" - "make sure that the fixations (ceiling brackets, wall post, wall brackets) are not displaced.- every year" 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 occurrence.To conclude, while the incident occurred the maxi sky 600 ceiling lift was being used for resident transfer.The installation was unstable and from that perspective, the system was not up to the manufacturer's specification at the time of the incident.Although no serious injury took place, we have reported investigated event to competent authorities, due to the fact that such circumstances with patient attached on the ceiling installation rail system upon recurrence may pose a resident at risk.

• Brand Name: MAXI SKY 600
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X5Y 5; CA J1X5Y5
• MDR Report Key: 6607261
• MDR Text Key: 76520073
• Report Number: 9681684-2017-00041
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: LD10203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2018
• Distributor Facility Aware Date: 05/08/2017
• Device Age: 10 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 05/08/2017; 01/31/2018
• Supplement Dates FDA Received: 08/28/2017; 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 148