MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA PLUS; NON-AC-POWERED PATIENT LIFT

Model Number HEP0001-UK

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh received a customer complaint where it was reported that during raising the resident from the wheelchair with sara plus lift and sling, strap stitching on the active sling that holds sling to the lift failed.The resident fell back into a wheelchair from a couple of inches without any issues.

Manufacturer Narrative

This report is being filed under exemption e2012070 (b)(4).On 2017-dec-20 arjohuntleigh received information about an event, which occurred at the customer home in (b)(6) with the involvement of arjohuntleigh system: sara plus active floor lift and active sling.It was reported that during raising the resident (male, (b)(6)) from the wheelchair with sara plus lift and sling, strap stitching on active sling, that holds sling to the lift, completely detached from the sling.The lift was not being used for resident's transfer, but for physiotherapy in a standing position, while the wheelchair was still directly under him.As the resident was raised only a couple of inches above the wheelchair, he rested on the wheelchair without suffering any injury.When reviewing similar reportable events registered during last 5 years with similar fault description (strap stitching on active sling that holds the sling to the lift is coming undone or has failed completely), we have found a limited number of cases.On 2018-jan-09 the customer was visited by arjohuntleigh representative to perform the inspection of the involved sling and lift device.No malfunctions regarding lift were reported which could have caused or contributed to the event.The sara plus lift was only 6 months old, it was found in "perfect condition" with some cleats broken.The sling was found in good condition apart fact that one of two loops, that holds patient to the lift completely detached due to stitching failure.The sling was almost 6 years old at the time of the event.The witness of the event stated that during lifting procedure the resident said that he felt like the sling was trapped.It cannot be ruled out that the attachment loop was caught by obstruction (in this case a wheelchair arm) when the resident was rising.The arjohuntleigh representative did the investigation and found damage to some lift's cleats (additional small part where the cord ropes holding the sling come through) and in his opinion it would have incurred from excessive force if the sling had become trapped.The combined weight of resident and the wheelchair was estimated to be approximately (b)(6), which is over 60 kg over the safe working load (swl), since the sling labeling indicates that its slw is 190 kg.If the sling loops were detected to be caught by obstruction and released before resident's lifting, this failure could have been avoided.The sara plus instructions for use (ifu kkx52180m rev.13) indicates multiple times that allowances must be made for obstructions in the lifting process description.It also warns: "when using the transfer and walking sling for the transfer operation the maximum lifting capacity is 140kg (308lbs).When using the same sling for walking practice the maximum lifting capacity is 190kg (420lbs).Do not exceed these weight limits." what is more it indicates that the sling lifetime is considered to be 2 years: "the expected operational life for fabric slings and fabric stretchers is approximately 2 years from date of purchase." based on review of similar events, product knowledge and description of this particular event the strap stitching is considered to broke due to the application of excessive force.During on-label use, one of strap of a sling would never be exposed to such a pull force.To conclude, the system - clip sling and lift was used for patient's care and in that way contributed to the alleged event.There was a system deficiency found (loop failure) and from that perspective the system did not meet the manufacturer's specification at the time of the event.We report this event to the competent authorities due to sling failure (strap stitching on active sling that holds sling to the lift failed) occurred during use with the resident.

• Brand Name: SARA PLUS
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 7192765
• MDR Text Key: 97876190
• Report Number: 3007420694-2018-00015
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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: HEP0001-UK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2018
• Distributor Facility Aware Date: 12/20/2017
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2018
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 91