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 Necrosis (1971)

Event Date 11/21/2019

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 kinetics concept inc (under registration # (b)(4)).From november 2012 until 2014 complaints related to these products 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 medwatch reports have been submitted under registration # (b)(4).From 30 may 2018 medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A patient had to remain in prone position 5 days because he did not tolerate supine position.When the patient could be turned to supine it was noticed that he received injury to nose, assessed as necrosis.Additional information was that the patient was very large and the facepack did not fit the patient properly.The nurse stated that the forehead pad was completely covering his eyes and resting on his nose.An arjo representative instructed the nurse on how to adjust the bed to accommodate patient's physique.The bed was operating correctly and therapy could have been resumed.

Manufacturer Narrative

Information gathered are evaluated.As soon as investigation conclusion is available a follow-up report will be provided.

Manufacturer Narrative

A patient sustained necrosis to his nose from rotoprone face pack.Following information gathered from the customer, the patient had to remain in prone position 5 days because he did not tolerate supine position.When the patient could be finally turned to supine position, it was noticed that he received injury to nose, assessed as necrosis (serious injury).Following the information received from the customer, it was deemed that several factors together influenced the injury.Patient needed to be placed in prone position for prolonged time.Because of patient¿s medical state, the patient could not be turned to supine position to assess his skin and check the proper placement in the bed.Patient size, described as ¿very large¿ (6'4 inch tall).Foot support boards positioned in a way that might push patient¿s head up too far in the face pack.Face pack was not adjusted and the forehead pad was completely covering patients eyes and was resting on his nose.A nurse stated she was not aware that the rotoprone surface can be adjusted to patient¿s size.Product instruction for use 208662-ah rev e includes warnings to minimize the risk of skin breakdown: ¿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¿; ¿the rotoprone therapy system can accommodate patient¿s between approximately 6 ft 2 in tall and 6 ft 6 in tall by removing the foot support boards."; "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¿.There was no product failure.The nurse was guided, by arjo representative, how to adjust the rotoprone bed surface and the therapy was resumed without further issues.The rotoprone therapy system is a patient care system for the prevention and treatment of complications associated with immobility.And although the use of the device is thought to help caregivers address potentially life-threatening conditions, proning itself may present inherent risk of serious injury, like pressure necrosis.The device was used for patient treatment when the event occurred, therefore played role in the event, however there was no device failure.We report this event because of serious injury sustained by the patient.

• 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: 9488344
• MDR Text Key: 175042011
• Report Number: 9681684-2019-00099
• 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,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 11/21/2019
• Supplement Dates FDA Received: 01/17/2020; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other