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

Model Number 209800-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjo was informed about patient sustaining deep tissue injury on right cheek, right knee, left arm.Patient was in prone position in rotoprone bed on (b)(6) 2018 for 16 hours.No bed rotation ordered by a doctor due to hemodynamic instability of patient.Patient turned to supine position for care later that evening on (b)(6) for another 16 hours prone with 15 degree angle rotations to the left and right.Pressure bruising was noted, additional mepilex added, adjustments made with chest pad, shin pads not used due to some shin bruising.

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 kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.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 #307420694.From (b)(6) 2018 medwatch reports will be submitted under registration #9681684.On (b)(6) 2018 arjo became aware of the incident involving rotoprone bed.Following the information provided, on (b)(6) 2018 the patient (41 years old male, weighing 101 kg) was in prone position for 16hours.No bed rotation was ordered by medical doctor (md) due to hemodynamic instability of the patient.Later that evening the patient was turned into supine position just for cares and then was proned for another 16 hours with 15 degree angle rotations to the left and right.The patient sustained deep tissue injury to the cheek and the area above the knee.The patient has been treated with mepilex dressing.Upon device inspection it was found in excellent condition with few scratches only.The bed was functioning correctly.It needs to be emphasized that 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.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 prone position for 32 hours total as per doctor's order, because of patient's medical condition.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, prolong 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.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.

• 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: 8230510
• MDR Text Key: 132502776
• Report Number: 9681684-2019-00004
• 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: 02/06/2019

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: 209800-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2019
• Date Report to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/31/2018
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 101