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

Model Number 209800

Device Problem No Apparent Adverse Event (3189)

Patient Problem Injury (2348)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, this product is 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 when investigation conclusion is available.

Event Description

A patient sustained face blisters on cheeks while on rotoprone.A foam dressing was used to treat an injury.No further information about injury was provided.Additionally, a nurse stated that they had another patient who sustained face blister and thus they discontinued the rotoprone therapy.This second event is reported under 9681684-2020-00030 (arjo ref #(b)(4).

Manufacturer Narrative

A customer called arjo asking to provide possibilities to protect a patient face during therapy on rotoprone.The customer stated that despite foam pads in the face pack, the patient had blisters on both cheeks.During a call the nurse added that earlier they had another patient with face blisters, thus decided to discontinue the rotoprone therapy (this event is submitted under mdr 9681684-2020-00030).Due to covid -19 no more information, regarding seriousness of these injuries, was made available.The rotoprone bed was inspected after it returned from rent as a part of preparation for the next rent.A cap that covers the load cell on the caster frame along with a brake caster and abdominal sling were replaced.These items are not related to the reported injuries from face pack.Product instruction for use 208662-ah rev e states: - ¿skin care - fitting the head support, face pack, proning packs or other accessory packs too tightly may increase pressure points, possibly leading to skin breakdown.Assess skin at frequent intervals depending on patient condition (at least once every four hours).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 essential to preventing serious skin breakdown.Do not leave patient in a stationary position in the supine or prone position for more than two hours.¿ - ¿face pack ¿ position face pack to ensure visibility of the eyes and to avoid pressure on or around patient¿s eyes, mouth and ears.Remove face pack at regular intervals to assess the eyes, ears and facial skin.Prolonged, increased intraocular pressure may cause eye injury, including blindness.Ensure all face pack buckles are secure before proning patient¿.- ¿face pack should be positioned as low on the patient¿s brow as possible without causing pressure on or around the patient¿s eyes, nose or mouth¿.Ifu includes also guidelines and steps that can be considered when managing potential skin complications that can be associated with prone therapy.The rotoprone therapy system is a patient care system for the prevention and treatment of complications associated with immobility.Although the use of the device is designed to help caregivers address potentially life-threatening conditions, proning itself may present inherent risk of injury.Caregivers should always address and discuss safety information, risks and precautions with the patient (or the patient¿s legal guardians) and the patient¿s family.The device was used for patient treatment when the event occurred, therefore played a role in the event, however there was no device failure that could cause or contribute to injury.We report it in abundance of caution because of limited information received.

• 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: 10082638
• MDR Text Key: 192156660
• Report Number: 9681684-2020-00029
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other