MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Model Number 209800-R

Device Problem No Display/Image (1183)

Patient Problem Death (1802)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event (h1) not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information initially received could be interpreted as the device not having performed as intended.When reviewing reportable events for the rotoprone device, we were able to establish that the issue described is considered to be an isolated event.The product involved in the incident is a rotoprone bed, serial number (b)(4).The device is part of the arjohuntleigh usa rental fleet and has been rented to (b)(6).The rental start day was (b)(6) 2015.The rotoprone therapy system is an advanced patient care system for the treatment and prevention of pulmonary complications.The rotoprone therapy system provides rotation up to 62° in both prone and supine positions, as well as trendelenburg / reverse trendelenburg positioning.The rotoprone therapy system is typically prescribed for patients with severe refractory hypoxemia at high risk of mortality.The user manual (e.G.#208662-ah rev c), which is supplied with each rotoprone, informs the operator how to correctly operate the device.It also provides detailed information in regards to operating the manual cpr function in case of emergency situation occurrence and leveling the device from trendelnburg or reverse trendelenburg position.In this particular case we were able to confirm that device involved in the incident was working according to the manufacturer specification.The unit was returned to the service center, tested and passed all requirements of the quality control on 2015-09-22.Moreover, the bed was left in prone over the night and no issues were observed.Unfortunately, the customer allegation regarding the screen issue could not be confirmed nor recreated.Moreover, the arjohuntleigh representative (present at the customer side when the event occurred) confirmed that personnel was fully aware of the device features and well trained on how to use them in case of the emergency situation.Due to this fact, the manual rotation was immediately started and patient was placed into supine position as required.It is worth noting that the facility staff was supported by the arjohuntleigh representative from the date of delivery, through the patient placement procedure, until the end of rental period.The company employee was in contact with the facility nurse to ensure that additional support and guidance in regards to patient placement and device functionality is available at any time.Based on the information collected to date and provided problem description, neither we (arjohuntleigh) nor the facility, in which the event occurred, have been able to establish correlation between the patient death and the device.In summary, the device was being used at the time of event and therefore played a role in it.However, arjohuntleigh was able to confirm that the device was working as intended after the event and did not fail to meet its specifications.Unfortunately, it was reported that the patient died, therefore it was decided to report this event due to the patient outcome, to be perfectly clear and transparent in the approach.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

The company representative called the facility in the morning on the date of the event to see how the patient was doing.She was informed that the patient has not been placed on the rotoprone yet but was being prepped to.Around 11:00 am (same day), the representative arrived to the facility and was informed that patient coded during transfer from icu bed to the rotoprone device.She stated that upon her arrival the patient was already on the rotoprone surface, getting cleaned up.With a supervision of arjohuntleigh representative, the facility staff led by the registered nurses (rn) correctly placed the patient and successfully started the prone therapy.The company representative walked the staff through a quick screen refresher procedure and gave some tips regarding skin protection (the patient's skin condition was found to be in a bad shape prior the placement).She remained with the patient and the staff for about half an hour more and left.After 20-30 minutes later, the nurse called the representative and stated that the screen abruptly went black.A basic troubleshooting was performed and screen started working again.A few minutes later another nurse from the facility called and said that they were running code on the patient and they had to manually supine her as the screen was still frozen.The manual rotation worked as designed, however the patient still remained in the reverse trendelenburg position and they needed the bed surface to be flat.The facility staff was assisted via phone in bringing the bed into the flat position with the two buttons at the bottom of the foot end of the bed, as indicated in the user manual.It has been stated by the company representative that there was no delay in treatment due to the screen issue.The facility staff was aware of the emergency features and act accordingly, the patient was immediately supine and the code was initiated.Nevertheless, it was decided that due to the screen issues another bed should be delivered to the facility for swap.The nurse agreed and stated that they were going to stabilize the patient a bit more prior the transfer to the new bed.Upon the delivery of a replacement bed it was found that the patient did not survive the last code and died right before the bed arrival.The patient was a late intervention sepsis with a very unstable condition.

• Brand Name: ROTOPRONE
• Type of Device: ROTOPRONE
• 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 78219 ; 2103170412
• MDR Report Key: 5156910
• MDR Text Key: 28650027
• Report Number: 3007420694-2015-00200
• 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
• Remedial Action: Inspection
• Report Date: 10/16/2015,09/18/2015

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: Nurse
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Distributor Facility Aware Date: 09/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• 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