MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800-R

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was informed that rotoprone bed automatically returned to supine position with back hatches open but the nurse wa able to close them.A technical service who was called for support discovered that manual release lever was released.There was no injury in regards to this issue.We report this event because it may result in patient fall and serious health consequences if the hatch remained opened.

Manufacturer Narrative

It was reported that rotoprone bed automatically turned from prone to supine position without user intervention with upper and middle hatches open.The therapy started on automatic rotation set to 45 degrees for 30 minutes each side, no pause at the centre.The report indicated that when patient was on right side in prone position, the bed suddenly flipped to supine without touching it.The staff members were able to close the hatches.An arjo technical service who answered the call advised the nurse to check the emergency release handle, and it turned out it was released.The beaded tie was attached but broken.The nurse indicated that they did not break or release the handle during his shift.The patient was placed on another bed until a replacement rotoprone arrived.We have investigated the reported case and the conclusions are following.The responsible manufacturer performed a simulation test and concluded that when the bed is rotated to prone using the automatic rotation, and emergency release handle becomes disengaged, the tension on the belt will become loose.If no one is touching the bed at that time, the bed will suddenly rotate and will turn back to supine.Utilization of the emergency release feature disarms all safety alarms.The emergency release handle is secured with a beaded tie.When the emergency release is pulled, the beaded tie breaks.Beaded tie is replaced during each quality control of the bed.Arjo's technical service found that the emergency release handle was not engaged.The beaded tie was attached but broken.When the bed returned to the service center it was evaluated and no fault was detected.The rotoprone had been running for 65 hours without any issues.Even though it remains unknown why and in which circumstances the emergency release handle was disengaged, in such situation when the bed is in automatic rotation and the emergency release handle is disengaged, the expected behaviour of the bed is to turn back to supine, regardless of open hatches.Therefore, the bed malfunction can be excluded.This can be supported by the inspection from arjo service personnel after the event where no fault was detected.The rotoprone was running for 65 hours and no error was detected in this period time.When reviewing reportable complaints for the last 5 years we have found one another complaint, where emergency release handle was disengaged causing the surface to rotate freely with unsecured patient on the bed.In summary, the rotoprone bed failed to meet its performance specification due to operational error, the bed evaluation revealed no fault.The device was used for patient treatment and therefore played role in the event.We report this event due to the risk of fall if the situation reoccurs, as the bed moved suddenly with unsecured patient in the bed (back hatches were opened).Fortunately, in the reported even, the two caregivers were able to close hatches, before the bed turned to supine.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 8425350
• MDR Text Key: 138967721
• Report Number: 9681684-2019-00021
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other