MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTORESTDELTA

Device Problems Detachment Of Device Component (1104); Unintended System Motion (1430)

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

Event Date 01/31/2015

Event Type  malfunction  

Event Description

Initially it has been claimed by the facility that the rotorest bed was ordered from the vendor and was delivered to the critical care unit a few hours later."the agent who responded to the request reported the he could only deliver and zero out the bed and that there was no rep available to set up the bed.After consulting with the physician and nursing leadership, it was determined that the pt needed to be placed on the rotorest bed.The critical care unit nurses were able to get the rotorest bed set up and the pt was transferred safely into the rotored bed." the next morning after placing the pt on the device, "there was a loud 'clunking' sound when the pt was turned 40 degrees for hatch cares.The lower left panel (containing the lowest hatch) had a disengaged pin, and it came undone from the side of the rotorest frame.The bed rotated slowly and carefully to right side and was able to re-engage panel.Three people were required to replace the panel with the pt in the bed.Later that same day, there was a loud 'clunk' when the pt was turned 40 degrees to the left to do hatch cares.The lower left panel (not hatch) of the bed had a disengaged pin holding the panel to the frame.Again, it took three staff to get the issue fixed." facility has contacted arjohuntleigh rep via a phone call and find out that no additional rotorest beds have been available.Facility has been instructed not to turn the pt to an angle greater than 20 degrees.The pt was scheduled for surgery early the next morning and the rotorest bed was discontinued after surgery.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the mfg site kinetics concept inc (under registration number (b)(4)).From (b)(6) 2012 to (b)(6) 31 2014 medwatch reports related to complaints of this product were submitted under registration number (b)(4).Since this registration number is no longer valid, reports related to complaints of this product will be submitted under registration number (b)(4).When reviewing similar reportable events for rotoprone, rotorestmi and rotorest delta therapy system, we have been able to find one similar fault description compared to the situation investigated here: hatch's locking detent coming off.There is no trend observed for reportable complaints with this failure for rotorest family beds.Based on the collected info, we have been able to establish that the pt (weight of (b)(6) pounds, described as retaining weight water) who was placed on the device exceeded its maximum pt weight which is (b)(6) pounds (counted together with the accessories).It has been reported by the arjohuntleigh service mgr who was directly in contact with the facility regarding this particular event that the bed panel/hatches on which the pt's weight is cumulated would flex/bend slightly when being under load greater than defined in the product labelling (pt weight and change of gravitational pull) and as a result the panel pin could pop loose form either the flex/gravity or the pin not being 100% fully seated in the receptacle (or a combination of both).The device has been inspected by an arjohuntleigh rep who found that the device was in full working condition.No issues have been found.Initially, the customer raised the allegation that not enough local support has been given to the facility staff when they request help with placing the pt on the device.It has been clarified that the call rep failed to follow standard operating for confirming pt height, weight, and contacting the internal placement lead to assist the placement.In order to prevent reoccurrence in further the service team has re-communicated procedure and has been provided formal placement training in order to ensure that proper placement of the pt and to provide a solid operational in-service with the staff.A copy of the placement guide can be provided to the facility on a request.The facility has been made already aware of the above conclusions.In summary, the device failed to meet its specification, 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 a remote 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: ROTORESTDELTA
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219 000
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4664747
• MDR Text Key: 5684368
• Report Number: 3009988881-2015-00031
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 57 YR
• Patient Weight: 143