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 03/16/2018

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 (b)(6) 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 any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A customer called on 24-hour phone line reporting several issues: they could not lock the head support piece from going up and down, the buckle was stuck all day, the hatch was hard to close.There was no injury reported.Arjohuntleigh clinical consultant provided guidance and explanation that the head support is design in a way to not restrict head and neck movements.A service order was placed for hatch and buckle issue.The service consultant who responded to the service order, reported that additional in servicing was required by the customer and that there was nothing wrong with the bed.The bed is currently on rent at another account.We report this incident taking into account an allegation of buckle being stuck and due to potential for a death or serious injury if the malfunction was to reoccur.

Manufacturer Narrative

On 16 march 2018 a customer called on 24-hour phone number (linc number) dedicated to rotoprone users reporting couple of issues the nurse experienced while using the bed.The nurse stated that the second buckle had been stuck all day.Additional issues reported referred to the head support which was not locking from going up and down and the lower back hatch which was difficult to close.Patient was stable, no injury occurred as a result of the issues.An arjohunteigh representative (linc operator) during a call explained that the head support movement is normal bed operation, which has been designed that way to protect patient's head and neck.An arjohunteigh service technician who was sent to the facility to verify allegation related to hatch and buckle, found no issue with the bed.The allegation of hatch being difficult to close could not be confirmed.No issue with the buckle was detected.The bed was quality control checked on 28 march 2018 after the incident.No fault was identified.A service technician while visiting the customer on (b)(6) 2018 stated that they required additional training.Part of the training included instruction of how to open the buckle.On (b)(6) 2018 another service technician visited the customer again, and received confirmation that there was nothing wrong with the bed.When reviewing reportable events for the rotoprone therapy system we were able to establish that there have been complaints for the buckle inability to open.Based on that we can point out two possible causes: mechanical failure of the buckle or straps were tighten too tightly.In case the issue is related to straps being tighten too tightly, in order to open the buckle, a force needs to be applied on the proning pack pushing it down, then the tension built in the buckle release mechanism is reduced and the buckle can be opened.In summary, the arjohuntleigh device played a role in the event as it was used for patient treatment.The device buckle was reported as stuck, however, the technical inspection of the rotoprone device revealed that there was no technical failure identified, and the device was performing according to the manufacturer specification.We report this event to the competent authority because of an initial allegation of the product deficiency (issue with buckle opening) and potential for injury that could result from that failure.

• 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: 7424704
• MDR Text Key: 105894791
• Report Number: 3007420694-2018-00089
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other