MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600; FSA

Model Number LD10205

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Arjohuntleigh received a complaint where it was indicated that stitching inside of the red loop of the sling failed based on the information received.No injuries and no patient involvement was reported.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 complaints with this failure mode is currently considered to be low and stable and slightly increasing.It has been established that the ceiling lift (maxi sky 600) and the sling were not being used for patient handling at the time of the event.No patient involvement was reported.Although the focus of the complaint was on the sling, no malfunctions were indicated regarding the lift.During our investigation one sling was found with red loop stitching inside loop failed, therefore, the sling was found to not have been to specification.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 this sling, especially since one of attachment point of the red loop was broken.Therefore, the sling showing signs of unstitching, should be withdrawn and replaced.After reviewing the complaint it comes forward that the loop breakage occurs in general ways: as the pressure on the sling loop, in the opposite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.After this review, we can state the event outcome of the breaking off the loop, is not likely to happen when following the device labeling or the instructions for use (ifu).The sling is not likely to fail during the intended, correct use as described in the ifu, but that a failure can occur during a use error.We find it likely that the loop broke due to the loop suffering stress that is not likely to be encountered during on label use.From this evaluation it is would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents.We find this complaint to be reportable to the competent authorities based on the initial indications and in the abundance of caution.

Event Description

On (b)(6) 2015 arjohuntleigh received a complaint where it was indicated that stitching inside of the red loop of the sling failed based on the photographic evidences received.No injuries and no patient involvement were reported.

• Brand Name: MAXI SKY 600
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5213342
• MDR Text Key: 31121701
• Report Number: 9681684-2015-00068
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/10/2015,10/15/2015

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
• Device Model Number: LD10205
• 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: 11/10/2015
• Distributor Facility Aware Date: 10/15/2015
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/10/2015
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• 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