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

Model Number 209500

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/23/2018

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 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 any medwatch reports will be submitted under registration #307420694.The investigation was performed and the conclusions are following: it was reported that a patient (male, (b)(6)) developed deep tissue injury on the right cheek.On (b)(6) 2018 a patient was placed in static proning position without rotation for about 16 hours, accordingly to the direction from doctor of medicine.While rounding in the account on (b)(6) 2018, an arjohuntleigh employee noticed also that the patient was not placed in reverse trendelenburg position.After discussion the arjohuntleigh critical care clinical consultant had with the attending that day trauma md, rotation at 20 degrees bilaterally was initiated.Later the same day, during a follow-up call with the facility, an arjohuntleigh critical care clinical consultant learned that when the patient was turned back to supine position, a deep tissue injury was noticed (approximately 1.5-2.0 cm).The arjohuntleigh critical care clinical consultant stated that one time when the face pack was off, a mepilex dressing was placed over the injury.The rotoprone bed was inspected after the event and found in excellent condition with minimal scratches and wear noted at foot ends of side rails, which however are not related to the reported issue.User manual (ifu) 208662-ah rev.D states that proning itself may present inherent risk of a 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, 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", "place patient in reverse trendelenburg position to help minimize facial swelling/edema." in the complaint at hand per doctor's decision, the patient was placed in prone position without rotation and not in reverse trendelenburg for 16 hours.This itself might result in the patient outcome.There was no product failure.From the above analysis, it has been deemed that the reported incident is related to the techniques used while treating the patient.When reviewing complaints for skin injury, we (arjohuntleigh) have found reportable complaints in the past.When comparing their number to the number of orders placed for the rotoprone bed within the last 2 years (since january 2016 till january 2018), the occurrence rate equals (b)(4).In summary, the device was used for patient treatment when the event occurred and in that way played a role in the incident, however it did not fail to meet its specification, there was not failure found, the incident occurred because the patient was placed in static position for the prolonged time period.We report this incident, solely, because of a serious injury sustained.

Event Description

It was reported that a patient developed deep tissue injury on the right cheek.The patient was placed on rotoprone bed on (b)(6) 2018 in prone position.While rounding in the account on (b)(6) 2018, an arjohuntleigh critical care clinical consultant noticed that the patient was in static prone position without rotation.The issue was communicated to the nursing staff, who state that static positioning for 16 hours (patient left in prone position without rotation) has been directed by doctor of medicine.An arjohuntleigh employee noticed also that the patient was not placed in reverse trendelenburg position.The issue was raised to the attending trauma doctor of medicine and rotation at 20 degree bilaterally was initiated.Later the same day, during a follow-up call with the facility, an arjohuntleigh critical care clinical consultant learned that when the patient was turned back to supine position, a deep tissue injury was noticed (approximately 1.5-2.0 cm).The critical care clinical consultant stated the one time when the face pack was off, a mepilex dressing was placed over the injury.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 7276084
• MDR Text Key: 100307614
• Report Number: 3007420694-2018-00043
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 129