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 10/21/2018

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 kinetic concept inc (under registration #(b)(4)).From november 2012 until 2014 complaints related to this product 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

The nurse stated that the chest proning pack buckle would not release.The attempt to open the buckle was not effective.Since patient did not tolerate supine position, the patient was placed in prone position for further treatment.

Manufacturer Narrative

Additional information provided was that the facitily cut the buckle strap to release the patient.Currently, we are further collecting information for the investigation.As soon as all the data is available, the final report will be provided.

Manufacturer Narrative

Investigation was carried out to this incident and the conclusions are following.On october 21, 2018, arjo was informed by a nurse that the chest proning pack buckle on the rotoprone bed would not release.The attempts to release buckle by pushing in on proning pack side arms were not effective.The patient was not tolerating being in supine position, thus the patient was placed in prone position for further treatment.Information about the patient's condition and how the situation was handled is unknown.No injury was reported as a result of the issues.When reviewing previous complaints for buckle inability to open we were able to identify two situations in which buckle may not release: (1) mechanical failure of the buckle or (2) tension is built on the buckle release mechanism due to straps overtightening before the proning therapy or the patient can swell and push on the proning packs which generates extra tension in the straps.In the course of this investigation service records were reviewed by service technician, and we were able to confirm that when the bed returned from rental, no technical malfunction was identified and no parts were replaced.The asset was quality control (qc) checked when it returned from the rent and no issue was detected on this occasion.The rotoprone bed functioned as intended.Because of the absence of technical failure and parts replaced, it is possible to state that the most probable cause of the inability to unbuckle the proning chest pack buckle was tension built on this part.In summary, the arjo device played a role in the event as it was used for patient treatment.The bed failed to perform as intended as buckle could not release when buckle release mechanism was pressed.There was no injury reported in relation to this event.We report this incident to the competent authority because of potential for serious injury or death if it recurs.

• 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: 8073478
• MDR Text Key: 129166970
• Report Number: 9681684-2018-00093
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• 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: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9681684-12/21/18-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other