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

Model Number 209800

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

A call from a customer stating that: ¿stage iv pressure injury to nose related to face pack placement.¿ service history of the bed did not reveal any repairs related to the reported issue.

Manufacturer Narrative

On 22 may 2020 arjo received a call from a customer stating that patient sustained pressure injuries to nose related to face pack placement.Initial indication was that the patient sustained stage 4 pressure injury.But later, arjo sale representative clarified that the patient sustained deep tissue injury to his nose.According to sale representative, patient was placed in the bed improperly.As a result the bridge of the patient¿s nose was subjected to pressure during prone positioning.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.Prior to rent the bed was quality control checked on (b)(6) 2020 and again after end of rental period on (b)(6) 2020.No discrepancies were found.No repair was performed on the rotoprone device after the event, which would indicate that there was no failure.In summary, the device was used for patient treatment when the event occurred, therefore played a role in the event, but there was no device failure.We report this event because of serious injury 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: 10166869
• MDR Text Key: 199990835
• Report Number: 9681684-2020-00032
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR