MAUDE Adverse Event Report: ARJOHUNTLEIGH MEDICAL BEDS DIVISION ACCESSORIES - MEDICAL BEDS; NONE

Device Problems Break (1069); Detachment Of Device Component (1104); Device Maintenance Issue (1379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Please refer to importer report # (b)(4).

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the mfr site arjohuntleigh, a branch of arjo ltd.(b)(4).As of 2011, that number was de-activated due to the site no longer shipping product to the usa.Going forward, complaints related to this product are to be handled by arjohuntleigh, a branch of arjo limited med ab and any medwatch reports will be submitted.When reviewing similar reportable events for adjustable strap and handle, we have found two cases with a similar fault description to the one investigated here: van riesen adjustable strap and handle breakage during use.The adjustable strap and handle (mfr by another company - (b)(4)) has been the subject of a corrective field action by this supplier and in june 2010 we have issued a january 2010 following a notification from the supplier that a review of the performance of the strap and handle products had identified a risk that part of the strap retracting mechanism may break whilst in use.(b)(4) advised the potentially defective parts were produced between (b)(4) 2007 and (b)(4) 2009.This particular adjustable handle, which take a part in this event does not fall within the scope of this action - it has been mfr by another supplier.There is no trend observed for the reportable complaints with this failure mode for the van riesen adjustable strap and handle, which is a component part of the optional lifting pole accessory - intended to assist a pt in moving or turning on the bed, or when entering and leaving the bed.Based on the info collated to date, provided problem description and photographic evidence, it seems that the adjustable strap and handle which has been involved in the event has broken in the half.Photographic evidence, shows that the actual piece that has broken is the belt slot of the belt retractor housing which provides the adjustment of the strap.The break has occurred as the handle come under load, fortunately there was no pt injury - no medical intervention being necessary.The defective adjustable strap has the tractability mark showing that it has been manufactured on february 2004, making the item more than nine years old at the time of the event on (b)(6) 2013.The product instruction for use (e.G.# 746-138_s4) of the contoura 880 ( with which the accessory has been used during the event) - in section maintenance, inform the user that service procedure should be conducted annually by qualified and trained personnel.One of the step of the preventive maintenance procedure is examination of the handle and strap in order to check if there are any sign of damage, fraying or loose stitching.Strap and handle should be replaced if either are faulty.We have not received from the customer any service/ maintenance history against this referenced complaints, so we are not in a position to determine if adequate preventative maintenance was performed on these in accordance with our recommendations.Therefore, we would recommend retrain the customer staff to the device labeling.In summary the device failed to meet specifications, was being used at the time of the event and therefore played a role in the event.This particular failure is probably the result of prolonged used outside of the recommended operational life of the strap and handle.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ACCESSORIES - MEDICAL BEDS
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH MEDICAL BEDS DIVISION; unit 3 britannia park, trident dr.; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer (Section G): ARJOHUNTLEIGH MEDICAL BEDS DIVISION; unit 3 britannia park, trident drive; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste. 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 3723717
• MDR Text Key: 4276424
• Report Number: 1000381138-2014-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Remedial Action: Replace
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1