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

Model Number 209800

Device Problems No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh was informed that a patient, who was placed in rotoprone bed on (b)(6) 2018 developed multiple pressure ulcers to right and left thigh, left knee, shin, foot (assessed as stage 1 and 2, deep tissue injury).Because patient tolerated less then 2 minutes in supine position, a closer skin examination on (b)(6) was not possible.Physician ordered patient to be left in prone position with no rotations.Patient was in this position for more than 30 hours.Patient skin was assessed on (b)(6).Treatment provided: mepilex border.There was no device failure.

Manufacturer Narrative

An investigation was performed and conclusions are following: arjohuntleigh was informed by a customer about a patient sustaining multiple pressure ulcers to left knee, right thigh, left thigh, left shin while on the rotoprone bed.The rotoprone therapy system is intended to provide kinetic therapy (lateral rotation up to 62 degrees) and proning therapy with simultaneous 62 degrees lateral rotation while in prone positioning.The rotoprone is indicated for the treatment and prevention of pulmonary complications of immobility.The device is part of the arjohuntleigh us rental fleet and has been rented to customer north memorial health.The event scenario of the reported incident was following: the patient was placed by nursing staff on (b)(6) 2018 in prone position for 16 hours, with kinetic therapy up to 60 degrees right and left with bed in reverse trendelenburg position.On 28 february and again on 1 march a nurse attempted to place the bed surface in supine position for skin assessment.Because patient tolerated that placement for less than 2 minutes, the skin assessment was impossible.As reported by the customer a physician ordered to place the patient in prone position with no rotation.Patient remained in that position for more than 30 hours.When was placed to supine position on 5 march and 6 march for skin assessment, a pressure ulcers were noticed.As a treatment, mepilex border was applied.There was no bed malfunction, the device had been still in use with the patient.This facility staff had last training performed on february 2017 and october 2017.Before the asset was rented to the customer it went through quality control check on 9 february 2018 to ensure it is working in accordance to manufacturer's requirements.Post placement quality control performed on 8 march 2018 did not reveal any anomalous condition, the bed was working as intended.Rotoprone user manual (ifu) 208662-ah rev.D states that "proning itself may present inherent risk of serious injury", such as skin breakdown.There are, however, ways to minimize skin breakdown as per ifu: "assess skin at frequent intervals depending on patient condition (at least once every four hours)"."do not leave patient in a stationary position in the supine or prone position for more than two hours"."early intervention may be essential to preventing serious skin breakdown", "prolonged static positioning may increase risk of skin breakdown" in case bed is in prone position for more than 3 hours and 15 minutes, the alarm will be activated to warn that maximum recommended prone time was exceeded.As per ifu corrective action involves "return patient to supine position to assess the skin at frequent intervals.If patient remains in prone position in excess of this time, patient may be at risk of skin breakdown or other complications.Always follow physicians orders for prone time." in the investigated situation patient was placed in stationary prone position for more than 30 hours as per doctor's order.This itself might result in the patient outcome.There was no product failure.From the above analysis, it can be stated that a few factors might contribute to the incident, prolonged static positioning and patient medical condition.Please note, that the bed is used to help address potentially life-threatening conditions however the proning itself may present risk of serious injury such as skin breakdown.The bed is not intended to prevent skin breakdown but to treat complication associated with immobility.Review of similar reportable events, revealed that there have been reportable complaints in the past, associated with patient sustaining pressure ulcer during therapy.To sum up, the rotoprone therapy system was used for patient treatment at the time of event and thus played a role in the incident.However no failure was found during quality control inspection, the device met the performance specification.We report this incident solely because of a serious injury a 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: 7384889
• MDR Text Key: 103939865
• Report Number: 3007420694-2018-00078
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR
• Patient Weight: 85