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 Tissue Breakdown (2681)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4)).From (b)(6) 2012 until 2014 complaints related to this product were handled by (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A customer called to discuss skin breakdown the recent rotoprone patients sustained.It was stated that the skin breakdown was on several sites: heels, ankles, toes, knees, elbows, cheeks, shoulders, forehead, but no other specifics were provided.The customer did not reveal also information about stage of wound for the patient currently being placed on rotoprone.We report this complaint in abundance of caution because of allegation of skin breakdown and limited information provided.

Manufacturer Narrative

The investigation was performed and the conclusions are following: a customer called to discuss skin breakdown sustained by rotoprone patients.It was stated that the skin breakdown was on several sites: heels, ankles, toes, knees, elbows, cheeks, shoulders, forehead, but no other specifics were provided.No information how many patients received skin injury or what was the stage of an injury was provided by the customer.During the call an arjohuntleigh clinical educator critical care discussed ways that would help preventing skin breakdown occurring in the future.In the course of the investigation, an arjohuntleigh critical care clinical manager stated that the purpose of the customer call was a request to provide guidance for skin care.The arjohuntleigh critical care clinical manager confirmed that there was no patient incident.Please note, that product user manual (ifu) 208662-ah rev.D states that the proning itself may present inherent risk of serious injury, such as skin breakdown.There are, however, ways to minimize skin breakdown.Ifu states: - do not fit the head support, face pack, proning packs and other accessory pack too tightly as this may increase pressure point, possibly leading to skin breakdown, - skin shall be assess at frequent intervals depending on patient condition (at least every four hours), - common pressure points include face, ears, axilla, shoulders, sides and upper and lower extremities and those point shall be given extra attention to, - early intervention may be essential to preventing serious skin breakdown, - do not leave patient in a stationary position in the supine or prone for more than two hours, "prolonged static positioning may increase risk of skin breakdown", - "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", - "when supine, elevate heels off of therapy surface" becasue friction on the feet can contribute to skin breakdown.- place prophylactic shear/pressure pads on areas such as: cheeks, forehead, knees, etc.- do not place packs directly over toes, knees feet or top of foot.Apart from information included in ifu, there is 24-hour phone number available and dedicated specifically to rotoprone users who can call to discuss and receive guidance and support while using rotoprone bed.During the call they may request for guidance regarding skin care as well as seeking for support when operating the bed.There was no product failure.Following additional information received from the arjohuntleigh critical care clinical manager, it can be stated that the call made by the customer was to request for guidance regarding skin care, but no information that a serious injury actually occurred was provided.As per the arjohuntleigh critical care clinical manager, there was no patient incident.It is worth remembering, that pronig itself may present inherent risks of serious injury and that caregivers should make sure to discuss safety information, risk and precautions with the patient (or the patient's legal guardians) and the patient's family.In summary, there was not product failure, and no allegation of serious injury sustained by the patients.Initially we reported this incident solely because of information that patients sustained an injury, however in the course of the investigation it was deemed that the customer call to discuss skin care, but actually no serious injury occurred.Therefore, we deemed this complaint not reportable to competent authority.

• 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: 7233454
• MDR Text Key: 98742084
• Report Number: 3007420694-2018-00025
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other