MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

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 the manufacturing site kinetics concept inc from november 2012 until 2014 complains related to these products were handled by arjohuntleigh inc.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's.Based on the information provided and inspection of the device conducted by the arjohuntleigh representative, it has been determined that the cause of the device failure was the rotation drum cable, which was worn and additionally has a one end completely detached.The detachment of the one end of the drum cable's connector, disrupted primary the communication in the system, resulting in the screen being non-response to commands from the user, which has been claimed.This type of damage, especially the wear of the part, is usually associated with the improper resetting of the rotating surface to its original position (prone or supine) after the emergency release function being conducted.This kind of drum cable damage might occur through wear from multiple placements or a single incident.Unfortunately, it is not possible to determine exactly which situation lead to this particular malfunction.It is worth noting that on rotoprone devices, there is a safety measure which allows the caregiver to rotate the bed manually in case the automatic rotation is not possible.In summary, the device was being used, when the event occurred, for patient treatment, it failed to meet its specification, as it was not possible to rotate the device.The device contributed in the event outcome: a patient suffered a decrease in oxygen saturation as well as the bradycardia.Fortunately, after placing the patient on the new bed and rotating the proner/reverse trendelenburg position, the patient's oxygen saturation increased back up to over 90% and her heart rate increased to its previous 110 beats per minute.The patient stabilized and improved over the next four days.On 10 nov 2014, the patient's condition improved enough to discontinue rotoprone therapy.The patient was reported to have recovered and was in good condition.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: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4346532
• MDR Text Key: 18921012
• Report Number: 3007420694-2014-00123
• 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
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1