MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Please note that this product is no longer mfg and previous medwatch reports for this product may have been submitted for the mfg site kinetics concept inc.From november 2012, medwatch reports related to complaints for this product will be submitted under arjohuntleigh inc.When reviewing similar reportable events for rotoprone, we have not found another event with similar fault description compared to the one investigation here: inability to rotate the bed due to the issue with ribbon cable.Unfortunately, without having a detailed description of what occurred, we are left to review the limited info received from the customer per our best efforts, and compare it to our product knowledge.Based on the info collected to date, provided problem description and inspection of the device, we have been able to establish that the source of the device failure was ribbon cable, which was snapped - this cause the inability to rotate the device automatically.After replacement of the defective ribbon cables, the device worked in accordance to its spec.The product involved in the incident is a rotoprone bed; serial number: (b)(4).The device is part of the arjohuntleigh usa rental fleet.Please note that each device in the us rental fleet is checked before being released for a rental period with the next customer.One of the steps of this check is to ensure that the ribbon cable is double looped on the pt right side and that the toggle is in correct position.Review of the pre-quality check for the device involved at this event, has not revealed any anomalies in this area.It is worth nothing that on rotoprone devices, there is a safety measure which allows to rotate the bed manually in case the automatic rotation is not possible.Please note that in the complaint at hand, there was no reported injury to the pt as a result of this event.It has been decided to report this event in abundance of caution and in the bein of our policy of transparency.In summary, the device failed to meet its spec, was being used at the time of the event for pt treatment, and due to this played a role in the incident.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 no propose any further action at this time.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4591210
• MDR Text Key: 5631187
• Report Number: 3009988881-2015-00012
• 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: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1