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

Model Number 209500

Device Problem Insufficient Information (3190)

Patient Problems Skin Tears (2516); Tissue Breakdown (2681)

Event Date 10/22/2016

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 (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Based on performed investigation we have been able to state the following.Arjohuntleigh received information that a patient developed skin breakdown while being placed on arjohuntleigh bed - rotoprone.This issue was however not related to an arjohuntleigh device, but to non-arjohuntleigh endotracheal (et) tube.Following the information collected, et tube tape was being removed from the patient's face causing the skin breakdown.A nurse called (b)(4) hotline to receive a guidance how to minimize the skin tear on patient face.The nurse stated that a patient had facial breakdown.It was confirmed that when a nurse was changing the holder they caused a skin tear to left cheek and noticed a deep tissue injury on right cheek in the place where the hard plastic from the holder was located.There was no indication of the rotoprone therapy system malfunction or failure, the bed worked as intended providing the desire therapy.The asset had pre-placement quality control completed (qc) on 2016-10-18 and post-placement inspection completed on 2016-11-16.On both occasions the device passed qc checks, met specification and functioned as designed.Please note, that the customer may call on (b)(4) number (24 hour phone), which is dedicated to rotoprone users, in case they need a support, guidance or advice of how to operate the device or create more comfortable environment to the patient.In the described situation the customer took the opportunity from the accessibility of (b)(4) number to ask for guidance in patients treatment and positioning within the device.According to a nurse, the patient had facial edema (some prior to prone therapy) and friable skin, which may indicate that some injuries might have been related to the patient pre-existing medical condition.Based on the nurse statement that a deep tissue injury on right cheek was in the place where the hard plastic from the holder was located, it was concluded that the et tube tape used, which was non-arjohuntleigh device, caused and contributed to the issue.Based on the above, and the clear indication that non-arjohuntleigh product resulted in the event, we can only assume that the event could have been related to a patient medical condition, we do not know however what was the condition of non-arjohuntleigh product, therefore the root cause cannot be determined with certainty.Due to the nature of this incident we are reporting this event to competent authority taking into consideration a serious outcome of the incident.It has been established that rotoprone system was in use for a patient therapy at the time of the event but our review did not identify any direct indication of its contribution to the outcome of the event.Arjohuntleigh medical bed was found not to have malfunctioned (was performing to the specification) when the event took place.Since non-arjohuntleigh product was involved in the incident, the exact root cause cannot be determined.

Event Description

A nurse called stating that a patient had facial breakdown and they would like a support from arjohuntleigh clinical consultant to check if the staff is placing a patient with a hollister correctly.The facility was using hollister et tube holder.After 4 days when a nurse was changing the holder they caused a skin tear to left cheek and noticed a deep tissue injury on right cheek in the place where the hard plastic from the holder was located.According to a nurse, the patient had facial edema (some prior to prone therapy) and friable skin.It was verified that the et tube holder caused deep tissue injury to a patient due to constant pressure applied.Patient was stable on 65% of oxygen.It was verified during a call that the patient was being rotated in both prone and supine position (3 times prone/1supine to help minimize facial swelling and facilitate weaning).

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; PL 62-052, PL
• MDR Report Key: 6709859
• MDR Text Key: 79904051
• Report Number: 3007420694-2017-00156
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other