MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for kinetics concept inc.From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc., and any medwatch reports will be submitted.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted.Add'l info will be provided upon conclusion of the investigation.

Manufacturer Narrative

When reviewing similar reportable events for rotoprone we have not been able to find any similar fault description compared to the situation investigated here: buckle broke off.There is no trend observed for reportable complaints with this failure for any rotoprone family beds.Unfortunately, without having a description of what occurred and under which circumstances it took place, we are left to review the limited information received from the customer per our best efforts, and compare it to our product knowledge.Based on the information collected to date we have been able to establish that the buckle on the arm (chest) section broke off.Buckles are used to restrain a patient on the rotoprone when the patient is in supine and prone therapy.The buckle assembly functions much like a seat belt buckle with webbing connected on the right and left side of the bed and a tongue and buckle that get latched in the center of the bed to restrain the patient.The operator of the device is to click together the male and female end of the buckle and tighten the pack straps.Tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position.Buckle is released by pressing the button inside the buckle.The product involved in the incident is part of the arjohuntleigh usa rental fleet - each device in this fleet is checked before being released for a rental period with the next customer.One of the steps of this check is to verify that all patient's straps are in place, undamaged and that the buckles function properly.The device must be in full working condition in order to pass the test and be cleared for dispatch.Additionally, the product user manual (e.G.#208662-ah rev.C) which is delivered to customer with each rented device includes the recommendation that one of the step of the daily equipment check is inspection of packs, straps and proning pack buckles for wear, in order to ensure that all are in good condition and that these proning pack buckles lock securely.If any of the packs, straps or buckles appear to require service or replacement, arjohuntleigh shall be contacted.We cannot see reason or likeliness of breakage of the buckle occurring in normal use and feel that there must have been some additional factors, which have led to this situation.Unfortunately, with limited information available we are not in the position to confirm that some kind of misuse/abuse occurred at that time.Please note, that in the complaint at hand, there was no reported injury to the patient as a result.Nevertheless, as the circumstances under which the failure occurred are unknown and a more detailed description of what have occurred is not available, it has been decided to report this event in abundance of caution and in the vein of our policy of transparency.In summary, the device failed to meet its specification, it is unknown if it was used.Fortunately, there were no injuries sustained.Given the circumstances and the fact that this incident appears to be an isolated one, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout dr; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC. ; 4958 stout drive; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4898557
• MDR Text Key: 6830695
• Report Number: 3007420694-2015-00129
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No Information
• Date Manufacturer Received: 06/05/2015
• 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
• Patient Outcome(s): Other