MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SLINGS, LOOP

Model Number MLAAS2000-L

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint where it was indicated that stitching inside of the red loop of the sling failed based on the photos received.No injuries and no patient involvement was reported.

Manufacturer Narrative

(b)(4).Arjohuntleigh received a complaint where it was noticed that stitching inside of the red loop in the sling failed.The malfunction was discovered by inspection before use.No patient and no injuries have been reported by the customer.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed).The trend observed for reportable complaint with this failure mode is currently considered to be low and stable and slightly increasing.It has been established that this sling was not being used for patient handling at the time of the event.During our investigation one sling was found with red loop stitching inside loop failed and was found to not have been to specification.No information was received regarding the lift device which was used with this sling.However, the sling or system was not in use at the time for patient care and it did not cause or contribute to an adverse event, but it is the focus of our report and investigation.Tests carried out during the development of the sling, and in current production on every sling manufactured, would indicate the stitching of the loops meets the oem specification.A proper inspection of the sling should have detected the failure of these slings, especially since one of the attachments points of the red loop was broken and also that stitches of the strap connecting the head sport buckle to the shoulder loop failed.Therefore, these slings showing signs of unstitching, should be withdrawn and replaced.After reviewing the complaint it comes forward that the loop breakage occurs in general ways; as the pressure on the sling loop, in the opposite direction of that experienced in normal use which can be caused by the caregiver pulling the loops that way by hand, or, a much higher strain, where the loop/sling becoming caught in an obstruction.This appears to be an indication of the loop being broken due to the application of outside force that causes the break.(b)(4).

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4219168
• MDR Text Key: 5000947
• Report Number: 3007420694-2014-00106
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MLAAS2000-L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/29/2014
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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