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

Model Number 209500

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

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 (b)(4)¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).A follow-up will be provided when investigation conclusions are available.

Event Description

A nurse called to say that lock pin was stuck and despite attempts it could not be released.There was no patient injury.No failure was found during bed's inspection.

Manufacturer Narrative

The lock pin has three positions, in, out and in the middle.When the lock pin is stuck in ¿in¿ position, the patient surface will not rotate to prone.Product instruction for use and labelling attached to the bed foot end guides through correction process.Labelling states to disengage emergency release lever and slightly shift the patient surface to release tension on the lock pin.The nurse stated that there was no need to position the patient into prone because the patient was tolerating supine position and they were waiting for the doctor to determine if the patient can come off the bed.When the bed returned to arjo service center it was quality control check and no failure was found.In summary, the bed was used for a patient treatment and in that way played a role in the event.There was no mechanical failure, but the bed failed to meet its performance specification because of stuck lock pin.We report this complaint in abundance of caution due to lock pin being stuck and inability to release it.

• 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: 10412528
• MDR Text Key: 204224503
• Report Number: 9681684-2020-00049
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other