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

Model Number 209800-R

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration #(b)(4).From (b)(6) 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration #(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and medwatch reports have been submitted under registration #(b)(4).From (b)(6) 2018 medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A nurse called to report chest buckle defective.The buckle could not be opened.An arjo service technician who visited the customer found the button from the buckle jammed.They had to cut the strap to open the chest proning pack.The rotoprone bed was swapped out.When the bed returned to the arjo service center, the buckle was changed.There was no injury in relation to this event.

Manufacturer Narrative

The investigation has been completed and the results are following.A nurse reported that the chest strap buckle of the arjo rotoprone device was defective.An arjo representative who visited the customer found that the red button, from the buckle, jammed resulting in inability to disconnect the two components (female and male components).The buckle strap had to be cut in order to open the chest proning pack.There was no injury in relation to this event.The patient was transferred to another bed.The faulty bed was returned to the arjo service center where buckle, a faulty component, was replaced.The faulty component was further inspected.The buckle was opened up to examine the internal parts.It was found that the red button had 2 hinges broken (one broke away and the other was missing).According to arjo service technician the red button could have been pushed down but the buckle would not release.The inspection conclusion was that the damaged and missing hinges would prevent the button from functioning properly.It was confirmed that the buckle failure was related with a mechanical failure.Before the bed was released to the customer it went through quality process on (b)(6) 2019 in order to ensure the bed is in working order and ready for next rent.No anomalous condition was detected.It is unknown when and how the buckle was damaged.While reviewing complaints for the last 5 years we have found 6 complaints regarding buckle inability to open due to mechanical failure.To sum up, when the event occurred the device failed to meet its performance specification since buckle could not be opened due to mechanical failure.The device was used for patient treatment during the event therefore was directly involved in the event.

• 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: 8662676
• MDR Text Key: 202692149
• Report Number: 9681684-2019-00054
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• 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: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other