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

Model Number 209500

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

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 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

A nurse called arjo stating that piece of bed cushion stuck in the buckle, and they cannot release the buckle.

Manufacturer Narrative

Arjo received a call from a rotoprone user that they buckled the proning pack material into the buckle and could not release the buckle.The nurse did not want to rip the fabric thus asked arjo technical service for support.During a follow-up call a service technician received an information that the customer staff fixed the problem and bed was working correctly, no further assistance was needed.The bed returned to the service center after end of rental period where quality control was performed.No issues was detected, no repair was needed.The buckle could not be opened because a proning pack fabric stuck in the buckle.This issue was corrected by the customer staff and therapy could continue without further issues.In summary, the arjo device played a role in the event as it was used for patient treatment.The buckle mechanism could not release because of piece of material wedged into the buckle and from that perspective it failed to perform as intended.But there was no technical failure, the fabric from the pack was buckled into the buckle by a caregiver.There was no injury reported in relation to this event.We report this event to the competent authority due to allegation that buckle could not be released.When a buckle cannot be opened there is a limited access to a patient in case of emergency situation.

• 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: 9150159
• MDR Text Key: 219167969
• Report Number: 9681684-2019-00080
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other