MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; IKZ

Model Number 209800-R

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 04/18/2016

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 (b)(4).From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports will be submitted under registration #(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh has been contacted by facility nurse and informed that during use, the rotoprone's face mask was digging into the patient's nose and causing injuries described as deep tissue injury and purplish discoloration.Complaint was decided to be reportable based on the injuries sustained.

Manufacturer Narrative

(b)(4).Arjohuntleigh has performed an in depth investigation into the issue and concluded following: the product involved in the incident is a rotoprone bed, serial number: (b)(4), model number 209800-r.The device is part of the arjohuntleigh us rental fleet and has been rented to customer: (b)(6).Each device needs to pass the cleaning and inspection process and the quality inspection (conduced in accordance to approved work instructions before being released to the customer for rental period).We were able to confirm that the device passed all requirements of quality control on (b)(6) 2016 and was delivered to the facility the same day.Additionally, after the rental period ended, the device has been returned to the service center and submitted for quality control.It passed all requirements on (b)(6) 2016 and did not require a replacement of any parts that would be found relevant to the issue raised by the customer.Therefore we established that from technical perspective there was no malfunction and the device was up to specification.With the complaint at hand, we have been informed that during proning the patient forehead was not correctly placed on the mask, what resulted in the patient sustaining injuries described as deep tissue injury and purplish discoloration.The arjohuntleigh representative, a clinical consultant, contacted the customer in order to assist and was able to solve the issue by giving instruction how to make a proper adjustment of the facepack while patient is having a rotational therapy.The exact instruction was given in regards to repositioning the facepack, loosening the mask, adjusting the mouth plate and tightening the patient in the mask via side crank.She has also advised to consider an adjustment with crank when patient is prone to alleviate hyperextension of neck and pressure on nose.The customer stated that they will address these issues and call back with questions, if any.It is worth to be noted that no follow-up call from the facility has been registered, therefore the assistance given by phone was considered to be enough to solve the problem and allow safe usage of the bed until the rental period ended.Based on the documentation gathered, the bed has been used for 10 more days after the issue was raised.We were able to establish that this facility received a formal training on the rotoprone device before the event occurrence.Moreover, the user manual (#208662-ah rev.C) is being delivered with each device and provides all necessary information regarding proper patient placement in the head support and face pack and skin care routine.It is recommended that all chapters of the manual are reviewed before operating the unit.Within this document, the user is informed that fitting the head support, face pack or other packs too tightly may increase pressure points, possibly leading to skin breakdown.Assess skin at frequent intervals depending on patient condition (at least every 4 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 critical to preventing serious skin breakdown.The patient should not be left in a stationary position in the supine or prone position for more than two hours.Also, during the rotational therapy the caregiver should observe patient for movement or shift within packs.In regards to the face pack, the user is informed to position face pack to ensure visibility of the eyes and to avoid pressure on or around patient's eyes, mouth and ears and to 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.Based on the information gathered, we were able to exclude an actual device malfunction and deemed the user error to have contributed to the issue.The arjohuntleigh device has played a role in the event, as it was used for the patient treatment.The injuries sustained were classified as a serious injuries, thus the event was decided to be reportable to competent authorities as such type.Given the circumstances and the fact, that there is no trend observed for similar adverse events, arjohuntleigh does not propose any other action at this time.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• 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: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5657427
• MDR Text Key: 45284136
• Report Number: 3007420694-2016-00088
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/10/2016,04/18/2016

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Distributor Facility Aware Date: 04/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2016
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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