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

Model Number 209500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 03/26/2018

Event Type  Injury  

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

It was reported by the customer that a patient (male) sustained "bilateral unstageable pressure injuries to zygomatic process" (as per complaint description "patient has unstageable deep tissue injury to face/cheeks").A linc line operator who received the call reviewed proper placement as the customer was unsure if it had been followed and advice to use mepilex.It was noticed that the customer had left commercially available et (endotracheal ) tube holder - the anchorfast device at patient's cheeks without placing foam dressing under the et tube holder, the additional protection was placed on forehead and chin.Treatment provided: vaseline gauze was applied as directed by (b)(6).

Manufacturer Narrative

The investigation was performed and the conclusions are following: a patient developed a deep tissue injury to cheeks.During a call, a linc operator, clinical consultant noticed that the et tube holder was left on patient face without additional protection under it.Rotoprone user manual (ifu) 208662-ah rev.D indicate several steps to help managing skin complication that can be associated with prone therapy, in face area: "place prophylactic shear/pressure pads (hydrophilic polyurethane foam pads) on sacrum, elbows, cheeks, knees and anterior shoulders.Apply absorbent white foam to pressure points on the face, forehead, cheeks and under tubing holder.Apply hydrocolloid dressing or hydrophilic foam dressing on the forehead and chin." "assess skin at frequent intervals depending on patient condition (at least once every four hours)."early intervention may be critical to preventing serious skin breakdown".Apart from instruction given in user manual, as part of customer education arjo clinical consultant always recommends using additional protection on patient forehead and cheeks.After the event, the rotoprone bed went through post placement quality control check and no issue was found within the bed.From the above it seems that the root cause of the patient outcome is related to et tube holder application without additional protection under it.Review of similar reportable events, revealed that there have been reportable complaints in the past, associated with patient sustaining pressure ulcer during therapy.In summary, the rotoprone device was used for patient treatment when the event occurred and in that way played a role in the incident, however it did not fail to meet its specification, there was no failure found.We report this incident solely because of a serious injury a patient sustained.

• 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: 7446143
• MDR Text Key: 106011066
• Report Number: 3007420694-2018-00098
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization