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

Model Number 209500

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, this product is to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

A customer called to state they had an issue with rotoprone bed because the surface was stopping while moving into supine/prone.First they used manual rotation to rotate the surface with success, but this function stopped working too.They were not able to move the bed all the way prone or supine.Patient was on the right side¿in no apparent distress.There was no injury.Rotoprone bed control board was found defective.

Manufacturer Narrative

It was reported to arjo by the nurse that they (nurses) had an issue with rotoprone bed because the surface was stopping while moving into supine/prone position.After the nurses used manual rotation (emergency release lever) to rotate the surface, this function stopped working (customer stated that manual rotation lever was stuck).The nurses were not able to move the bed all the way prone or supine.Patient was on the right side in no apparent distress.There was no injury.When the bed returned to service center it was evaluated by arjo service technician, who found that the motor control board was defective.There was no issue with manual rotation.Motor control board was replaced.The bed was tested and confirmed as functioning correctly.The nurses allegation that the bed could not be turned because rotation lever was stuck was not confirmed.Failure of motor control board prevents the bed from automatic rotation but manual rotation is preserved.Product instruction for use (ifu) 208662-ah rev e (dated 04/2019) states: "cpr and manual rotation feature - caregivers and other hospital personnel are required to become familiar with the cpr function and the emergency release procedure for automatically or manually rotating the patient surface, as well as the other procedures required to access the patient in case of an emergency".Ifu includes information and drawings, which guide users through manual rotation to supine or prone.Drawing and instruction are also attached to the bed itself.Prior to rent, the bed was quality control checked on 27 apr 2020.No discrepancies were found.In summary, the bed was used for a patient treatment when it failed (motor control board was defective), therefore it did not meet its performance specification.This event was deemed reportable in abundance of caution taking into account customer initial allegation that the bed could not be turn both automatically and mechanically.After bed evaluation it was confirmed that manual rotation feature was working.An allegation that manual rotation lever was stuck could not be confirmed.

• 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: 10167096
• MDR Text Key: 195559487
• Report Number: 9681684-2020-00033
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other