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

Model Number 209800-R

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

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about patient sustaining deep tissue injuries to both cheeks while using rotoprone bed.The bilateral injuries were first noticed on (b)(6) 2018 and described as maroon in color at the time, but progressed to some blistering and open skin.A wound care nurse also noted very edematous face and tight ett tape around cheeks.Patient has been treated daily with mepilex dressing to face to help with wounds.

Manufacturer Narrative

The investigation was performed and the conclusions are following.On 12-dec-2018 arjo became aware of the incident involving rotoprone bed.Following the information provided on 9-dec-2018 the wound care nurse noticed the patient acquired deep tissue injuries to both cheeks.She described them as maroon in color.She also noted patient's very edematous face and endotracheal tube (ett) tape tight around patient's cheeks.Since (b)(6) 2018 the patient has been seen daily and has been treated with mepilex dressing to face, in order to help with wounds.Per customer, patient's wound was located near the tube (ett) tape however not related to the tape itself.Moreover it was confirmed that there was no additional protection applied to patient's cheeks prior to the injury.The last facility staff training was on 18-jul-2018 and 20-jul-2018.The trainings scheduled for 8-nov-2018 and 9-nov-2019 were canceled by hospital educator due to unknown reason according to arjo clinical educator, who rounded the customer at the time patient's injury was observed, the face pack was not positioned properly on patient's face.The patient had either slid down or had not been slid up high enough during placement as his eyes were not visible (obscured by face pack foam).Moreover the face pack was on very tight.Following, the arjo clinical educator advice, the patient was repositioned higher in bed and the nurses were educated how to reapply facemask and side packs against torso to prevent sliding down.The rotoprone bed was inspected after the event and found in good condition.The device was quality checked after the event and no fault was detected, it met manufacturer's requirements.Please note, that the rotoprone bed is not intended for prevention of skin breakdown, the prone therapy itself may present inherent risk of skin breakdown.Product user manual (ifu) 208662-ah states that "proning itself may present inherent risk of serious injury", such as skin breakdown.Ifu indicates possible ways that can be used to help manage skin complications that can be associated with prone therapy: "fitting the head support, face pack or other packs too tightly may increase pressure points, possibly leading to skin breakdown.Assess skin at frequent intervals depending on patient condition (at least every four hour).Give extra attention to skin at pressure points and locations where moisture or incontinence may occur or collect.Common pressure points include, but are not limited to, the face, ears, axilla, shoulders, sides and upper and lower extremities.Early intervention may be critical to preventing serious skin breakdown", "apply absorbent white foam to pressure points on the face, forehead, checks and under tubing holder:, "remove excess moisture and keep skin dry and clean at all time", "remove face pack at all times patient is in supine position", "remove face pack at regular intervals to assess the eyes and surrounding skin", "make sure that face pack does not touch the eye and only lightly touches the face", "place patient in reverse trendelenburg position to help minimize facial swelling/edema." however please note, that the manual includes only recommended guidelines.The final decision regarding the patient care is up to caregivers/doctors and should be based on patient's medical condition.The skin care guidelines is also included in the trainings provided to the customer, proper face pack placement is part of that training.In order to prevent the issue from recurrence it was explained to clinical nurse specialist, registered nurse and respiratory therapist how to reapply facemask so it would be applied correctly.Moreover they were educated on re-assessing patent's placement and checking side pack tightness frequently, as the tissue may shift during therapy.In summary, the 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 not failure found.The cause of the deep tissue injury the patient sustained was found to be related with an increased pressure on patient's face and body due to incorrect patient position in the bed.We report this incident because of a serious injury the 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: 8230461
• MDR Text Key: 132489310
• Report Number: 9681684-2019-00003
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention