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

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 07th february 2017, arjohuntleigh received customer complaint where it was reported that during transfer of resident with passive lift and sling, one of clips sling detached from spreader bar and resident fell as consequences.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).It was reported that during of patient transfer with passive lift and sling, clip detached from a lift spreader bar.Following the information received it is the most likely that the shoulder clip detached.It was informed, that as a consequence, the resident sustained an injury.However, additional information regarding injury was not released.An investigation was carried out into this complaint.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).The trend observed for reportable complaints with this failure mode is currently considered to be relatively low and stable.No malfunctions regarding lift and sling were reported which could have caused or contributed to the event.It can be established the lift and sling were being used for patient handling at the time of event occurrence but it appears it contributed to the event due to a use error.Passive clip sling is a product intended for assisted transfer of residents with limited ability to move.Passive clip sling should be used together with arjohuntleigh lift devices.Product's instruction for use (ifu) is provided with each device.Before every use, ifu (04.Sc.00-int1_2) instructs to assess the resident and describes the methods of use.The equipment shall be assessed against, inter alia, damage clip.Ifu provides also written and pictographic guidance regarding proper clip attachment process: "attach the clips (5 steps) 1.Place the clip on the spreader bar lug.2.Pull the strap down.3.Make sure the lug is locked at the top end of the clip.4.Make sure the strap is not squeezed in between the clip and the spreader bar.5.Make sure the straps are not twisted." the document guides, step by step, through a proper sling application.It is important to make sure that the clip sling is attached securely before and during lifting process.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It is not likely to come off during on-label use.It cannot go inward because it is stopped by the metal frame of the spreader bar.It cannot go outward because it is stopped by the metal end stop of the clip attachment lug.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.During the clip detachment the person is likely to fall away from the sling, toward the corner where the clip is not in place.Based on the information collected from the customer, we have learnt that the facility decided of its own on unauthorized modifications: volition to include the use of a carabiner to connect the sling clip to the connection lug nut on the hanger bar.Additionally, it should be emphasized that facility declined to provide additional information regarding the event, it was stated that they have "focused on [internal] training and policy for use of the lift".From the above we can conclude that this issue was caused by user error - user did not follow warnings regarding correct sling clip attachment and preserving patient's safety.The received information and our evaluation as described above are showing that if warnings and transferring procedures included in ifu were followed, there would be no patient at risk.To conclude, clip sling was used for patient's care and in this way contributed to the alleged event.No defect has been found within the clip, but since the sling clip detached from the spreader bar, it can be stated that the sling did not meet its performance specification.No serious adverse event occurred.We report this event to competent authorities in abundance of caution as clip detachment from a spreader bar may result in serious injury if inadequate procedure of sling clip attachment would recur.

• Brand Name: SLINGS, CLIP
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 4869828246
• MDR Report Key: 6379103
• MDR Text Key: 69106196
• Report Number: 3007420694-2017-00050
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Distributor Facility Aware Date: 02/07/2017
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other