MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; IKZ

Device Problems Device Inoperable (1663); Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for the rotoprone, we have been able to find one fault with the similar fault descriptions compared to the situation investigated here: detachment of the ventilator tube.There is no trend observed for reportable complaints with this failure for the rotoprone.Based on the information collected to date, it would appear that tube dislodged during the rotation process when it got caught on the protruding screws.It has been confirmed that the threaded inserts in the plastic part of the head end, were not stripped.Unfortunately, it is unclear of why the two screws were protruding in the first place - it seems that it could be either the wrong size of the used screw or there might have been some object which blocked the down flush of the screw to the trim.The device involved in the incident, is a rotoprone which is a part of the arjohuntleigh rental fleet.Each device in that fleet need to pass the quality check before being released for next rent.The inspection is conducted in accordance to the relevant work and quality check instructions which required to dissemblance, clean and install back the tube management system (tms) and head end component.Additionally, according to the device labeling - user manual (#208662-ah rev.C, dated on dec 2014) , delivered to the customer together with the device, the following recommendation/information are provided to the operator of the device: tube and line management - prior to activating rotation, assess the security of all invasive lines and tubes to accommodate a full 360° of rotation and minimize the risk of binding, disconnecting or dislodging.Tubes and lines should always have slack for rotation and patient movement.Tubes and lines must always be routed through and kept within either top frame hoop or the circular opening in the frame at the foot-end of the unit, just beneath the main display panel.Do not hang or tie any equipment or lines on sides of patient support frame; ventilator management - always rotate the patient surface from the supine position to the prone position toward the ventilator, to reduce risk of extubation; moving parts - keep all equipment, tubes and lines, loose clothing, hair and parts of the body away from moving parts and pinch points; before the device would start the potation to supine or prone position, the operator must follow the checklist displayed on the device screen -first point on that list is to check the tubing.In summary, in the event at hand, a one-off human error during inspection at the service process, namely omission of that step, cannot be excluded.Therefore it has been decided to conduct an "awareness" during the service training.At the same time, the operator of the device is informed about the need for checking the tubing before starting the rotation, in order to minimize the risk of tube detachment.The device was being used when the event occurred, therefore it played a role in the event.The device failed to meet its specification as two screws were protruding, which turned out to be a factor leading to the event.Given the circumstances and the number of similar events, 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.

Event Description

It has been claimed that the ventilation tubing got caught on the screws and dislodged, when the bed was going to prone position.Fortunately, the nurse was present and was able to reattached the ventilation tube.There is no information about any adverse outcome of the event.According to information provided by the nurse, two screws which are fastening the head end of the bed, appeared to be the wrong size.The decision was taken to pull out the screw completely and tape the pieces of the device together instead.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78219 ; 2103170412
• MDR Report Key: 5401165
• MDR Text Key: 37186286
• Report Number: 3007420694-2016-00012
• 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: company representative,user f
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/01/2016,01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2016
• Distributor Facility Aware Date: 01/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2016
• Date Manufacturer Received: 01/07/2016
• 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