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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo received a voluntary medwatch report uf report (b)(4) about rotoprone bed.It was reported that the emergency release handle opened and the bed started rotating from prone to supine on its own.The customer staff were able to stop the bed movement and the bed was brought back to zero degree, the emergency release handle was closed.There was no injury in relation to this event.

Manufacturer Narrative

Arjo received a voluntary medwatch report user facility report #3600510000-2019-8011 about rotoprone bed.It was reported that the emergency release handle opened and the bed started suddenly rotating from prone to supine position on its own.There was no injury in relation to this event.Based on our product knowledge we have established that the bed can move from prone to supine unintentionally when automatic rotation is selected and the emergency release is disengaged.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.Arjo investigated the case taking into account three theories: 1) the emergency release handle failed, thus it opened.Service history was reviewed for the involved bed and no repairs or parts replaced were found.Therefore, the customer allegation of bed malfunction (emergency release handle opened on its own) cannot be confirmed.2) the emergency release handle was pulled accidentally.The emergency release handle is easily accessible for an intentional usage during an emergency situation but it is not easily accessible around the bed for something that would inadvertently pull the handle.In order to open the handle, a user needs to grab it and pull.Therefore it is unlikely that the emergency release handle would be disengaged accidentally.3) the emergency release handle has not been closed after it was used, therefore opened on its own.Following product user manual, in order to open the handle a user needs to grab it and pull, once patient surface has reached 0 degree supine, lock pin should be pushed in to stabilized the bed surface and emergency release handle needs to be re-engaged.The customer stated in the report that " bed was manually brought back to zero degree and lock pin was pulled, rn zip-tied red manual rotation latch shut." information that the nurse zip-tied the emergency release handle would indicate that emergency release handle was used and the confirmation of it is beaded tie (its function is similar to zip tie) detachment.It would seem that emergency release handle might have not been fully engaged after it was used.When reviewing reportable complaints for the last 5 years we have found two another complaints, where emergency release handle was disengaged inadvertently causing the surface to rotate freely.In summary, the rotoprone bed failed to meet its performance specification, most likely, due to operational error.Service history did not show parts replaced or repaired, therefore we concluded that there was no technical failure.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.

• 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: 8739731
• MDR Text Key: 149370278
• Report Number: 9681684-2019-00059
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 86