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

Model Number MAA2040M-XL

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by the manufacturer arjohuntleigh (b)(4) on behalf of the importer (b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

On (b)(6) 2017 arjohuntleigh received customer complaint where it was reported that during the beginning of transfer of resident from bed with sling, leg sling clip detached from spreader bar of lift.The resident was about 20 centimeters up to the mattress when the event occured.No injuries were reported as consequences.

Manufacturer Narrative

An investigation was carried out into this complaint.It was reported that at the beginning of patient transfer from a bed a clip detached from a lift spreader bar.It was stated by the customer facility (b)(6) that a leg clip was not properly attached and when a patient was approximately 20 cm above the mattress the clip came off.Additional information was that the patient (male, weight approximately (b)(6) ) was agitated.There was no injury sustained in relation to this incident.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.Arjohuntleigh's clip slings¿ are designed for use with four-point dynamic positioning system (dps) spreader bars.Product's instruction for use (ifu) which is provided with each device indicates and warns that: "resident with spasm can be lifted, but great care should be taken to support the resident's legs", "at any time, if the resident becomes agitated, stop transferring/transporting and safely lower the resident", "to avoid injury, always assess the resident prior to use", "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process".Ifu provides also written and pictographic guidance of proper clip attachment: "attach the clips 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 documents guides step by step through proper sling application with patient on a bed.It states to place the led flap underneath the resident's leg, attach the sling, recline the spreader bar if needed and slightly lift the patient to create tension in the sling.There was no product failure as per customer examination, the customer stated that the clip was not attached securely and that the patient was agitated.These both factors might have led to the sling clip detachment.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.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.In conclusion, the passive 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, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6840847
• MDR Text Key: 86110141
• Report Number: 3007420694-2017-00182
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

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
• Device Model Number: MAA2040M-XL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2017
• Distributor Facility Aware Date: 08/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2017
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/04/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/27/2017
• 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
• Patient Weight: 100