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

Model Number HEP0001-UK

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 18th august 2017 arjohuntleigh received a customer complaint where it was reported that during the resident transfer with sara plus lift and sling, strap stitching on active sling that holds sling to the lift failed.The resident was lowered back in to a wheelchair without any issues.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).The sling was requested for return to the manufacturing site in order to perform further evaluation.The return process is in progress.Additional information will be provided upon conclusions of the manufacturer's investigation.

Manufacturer Narrative

This report is being filed under exemption e2012070 by the manufacturer arjohuntleigh (b)(4).On 2017-aug-18 arjohuntleigh received information about an event, which occurred with the involvement of sara plus active floor lift and active sling at the customer home in (b)(6).Initially, it was reported that sling loop that holds sling to the lift, completely detached from the sling whilst hoist was being used with the resident.Following the additional information provided, the lift was not being used for resident's transfer, but for physiotherapy in a standing position, while his wheelchair was still directly under him.It was reported that during the resident lifting from a wheelchair, a ripping sound was heard from the safety belt.The resident was lowered back into a wheelchair safely, without any issues.The stitching of attachment loop for cord, that holds sling to the lift, completely detached from the sling.The resident was raised and lowered twice prior this failure occurrence.When reviewing similar reportable events registered during last 5 years with similar fault description (strap stitching on an active sling that holds the sling to the lift is coming undone or has failed completely), we have found a limited number of cases.No malfunctions regarding lift were reported which could have caused or contributed to the event.The sara plus lift was only 2 months old, it was found in "excellent condition".One out of two loops of the sling intended to hold patient to the lift completely detached due to stitching failure.The product return of faulty sling to manufacturer for investigation purpose was initiated.However, on 2018-jan-16 it was confirmed by domestic courier service (dcs) that the faulty sling has been lost in delivery.In this regards, for reasons beyond out control, further analysis of the sling was impossible.Based on the follow-up information provided for this specific complaint, the resident was raised and lowered twice without any problems prior stitching failure.It cannot be ruled out that the attachment loop was caught by obstruction (e.G.Wheelchair arm) when the resident was lowered for a second time.If the sling loops were detected to be caught by obstruction and released before resident's lifting, this failure could have been be avoided.The device instructions for use (ifu kkx52180m rev.13) indicates multiple times that allowances must be made for obstructions in the lifting process description.The sara plus active slings ifu (04.Sg.00 rev.2) describes the proper sling applying taking into account to check sling attachment before patient lifting: "make sure the sling is attached correctly and the cords are locked.If any adjustment is needed, lower the resident to make sure that the weight of the resident is taken up by the receiving surface before removing the clip/strap." based on a review of similar complaints, product knowledge and test performed the strap stitching failure is likely to occur only when the product is used against the instruction for use recommendations and is subjected to an additional, external excessive force.During on-label use, one of strap of a sling would never be exposed to such a pull force.Despite our best efforts we are not able to determine the root cause with certainty.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 based on the initial indication that sling failure (strap stitching on an active sling that holds sling to the lift failed) occured during resident transfer.

• Brand Name: SARA PLUS
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6866990
• MDR Text Key: 87309159
• Report Number: 3007420694-2017-00191
• 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,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: Physical Therapist
• 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: 08/18/2017
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2018
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 08/18/2017; 01/16/2018
• Supplement Dates FDA Received: 11/07/2017; 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other