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

Model Number 209800

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

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 november 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 30 may 2018 medwatch reports will be submitted under registration #:(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

The customer reported that they could not open the buckle from pelvic prone pack.The buckle strap was cut.There was no injury.

Manufacturer Narrative

The investigation has been completed and the results are following.A nurse reported that the pelvic pack could not be opened.An arjo representative who answered the call advised to cut the strap in order to open the pelvic proning pack.There was no injury in relation to this event.The faulty bed was returned to arjo service center where buckle, a faulty component, was replaced.A service technician who inspected the bed found that the red button from the buckle was broken and would not release.This would indicate a mechanical failure of the buckle.Before the bed was released to the customer it went through quality process on 29 july 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 became broken.While reviewing complaints for the last 5 years we have found 8 complaints regarding buckle inability to open due to mechanical issue.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: 8991652
• MDR Text Key: 219172984
• Report Number: 9681684-2019-00073
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other