MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE; IKZ

Model Number 209800-R

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/15/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for rotoprone, we have not found any similar fault description compared to the situation investigated here: during the emergency situation, bed was not rotating back to the supine position, as the system does not identified closed hatch and the facility staff decided not to use manual emergency feature.There is no trend observed for reportable complaints with this fault scenario for rotoprone.In accordance to the device labelling, user manual (e.G.#208662-ah rev.C) which is delivered to the customer with each rented device, section 'powered cpr', one of the first step while using the automatic cpr is closure of any open hatches and ensure that hatch latches are secured.The bed movement (into the supine position) will stop if an unsafe operating condition occurs (e.G.Opened hatch).Once the alarm 'buckle/hatch/hoop open alarm' is triggered, the customer is advised to follow the instruction on the screen: check each item listed.Once all pack, hatch or hoop conditions are corrected, therapy should resume automatically.However, if any of the hatches would be opened an audio alarm becomes triggered.The device has also a manual override system - emergency release for cpr/supine position, that the user could have used to return the patient to a flat position in a situation when the hatch would be wrongly identified as an opened one, which could prevented automatic rotation to the supine position.It was explained by the facility, that the staff felt that the electrical cpr process better ensured patient safety because it requires all door hatches and strap mechanisms be securely fastened before rotating the patient, while the emergency release mechanism does not.However, at the time of event it was assessed by the clinical staff that the hatch identified by the system as opened one was actually closed.Still, the decision was taken not to use the manual emergency release even when the personnel involved in this event knew that feature.The device labelling describe the procedure for the emergency release for cpr/supine position with the following steps: close any open hatches, ensure hatch latches are secure; pull emergency release handle toward foot of unit to disengage belt drive (the emergency release handle is secured by beaded tie, in order to use this function the tie need to be break).Ensure lever is pulled all the way open so that handle is resting back against unit.Manually rotate patient surface to supine position in the opposite direction from which the unit was proned.Once patient surface has reached supine position, the lock pin shall be fully pushed in to stabilize patient surface and emergency release handle shall be re-engaged.Further steps are related to unbuckle and stow check pack and starting the cpr procedure.There is also an information that the engagement of the emergency release feature disarm all safety alarms.Also in section 'safety information' of the device user manual the following statement can be found: cpr and manual rotation features - caregivers and other hospital personnel are required to become familiar with the cpr function and the emergency release procedures for automatically or manually rotating the patient surface, as well as the other procedures required to access the patient in case of an emergency.The device involved in the event was inspected by an arjohuntleigh representative at the customer side and after returning the unit to the rental center.The device was found to be to specification, no failure has been found.It was not possible to recreate the event.On a rotoprone device there are two alarms that could have prevent the patient surface from returning to the supine position: a buckle alarm and/or hatch alarm.Both of them have been checked.The buckle alarm worked correctly - there were no damage to the tape switches and striker plate where the buckle alarm originates.It was confirmed that the alarm was triggered if the buckle was open or not tighten enough.Once it was installed properly, no alarm occurred.The alarm was tested with and without load (320 lb water dummy).Proper operation of the emergency release lever was also verified - the buckle alarm would not prevent the patient surface from returning to supine if emergency release lever was used.The second alarm, hatch alarm, occurs when one or more of the four hatches (on the backside of the patient surface) are opened.These hatches can be opened while the patient is in the prone position.If one or more hatches are not closed during the rotation a patient from the prone to the supine position, the alarm will prevent rotation at 62 degree.The hatches are locked in place by metal pins.The pins activate a switch that lets the device know if the hatches are closed.The hatches and pins were inspected - no visual and operational defects of the hatches were identified.Correct operation of each from 6 switches was verified individually by opening them and checking if alarm was activated.After closing the hatches the alarm was deactivated and the patient surface was free to rotate to supine.If there is a hatch alarm the emergency lever would have allowed the patient surface to return to the supine position.The allegation was also raised by the facility that once the patient was in the supine position and unstrapped, it was difficult to get the top pads out of the way to allow the cpr.Chest pack are placed onto the patient's torso (it is according to one of the step of placing the patient on a device) - all pads, packs and swing arms are used to secure the patient during the rotation movement - in order to prevent patient's migration/shift or unexpected exit from the device.In summary, the device was being used at the time of the event and it failed to operate as intended, however most probably it did not suffer a malfunction but stopped performing as intended due to a user error.In this way the device contributed to the outcome of the event - delay in providing the cpr therapy and patient death.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

Initially, it has been claimed by the facility that the day after the delivery of the rotoprone, the event took place - the device did not turn during a code blue (the patient was in the prone position for 9 hours from 16 hours prone session - rotating 20 degree in each direction).Unfortunately the patient suffered cardiac arrest.Facility states that two doctors have tried to turn the device for approximately 10 minutes and were not able to access the patient.Unfortunately, the patient had deceased.At the time of delivery of the device, an in-service for the medical staff was provided by arjohuntleigh.After the event, visit of an arjohuntleigh representative has been requested by the facility, in order to check the device and ensure that it works properly before releasing it.The following information had been collected during that visit: while turning the patient back to supine from the prone position, an alarm was going off (bottom hatch not close alert) preventing the bed from turning back to supine, the staff said that the alarm on the screen was for one of the prone pack (top hatch) sensors.The staff said that the hatch was not having contact with the frame, and as a result the alarm would go off while turning to supine, preventing further rotation to supine position, the staff had push the prone pack (top arm hatches) in order to deactivate alarm are re-start the rotation, however once it was released the alarm was triggered again and rotation was stopped (facility staff claimed that it was verified that the hatch was closed), the staff tried this several times and finally over the course of 10 minutes they finally got the patient into the supine position, the beaded ties securing the manual rotation lever and the emergency release handle were attached, which means that the emergency manual rotation procedure was not used for a code blue cpr, during the visual inspection of the device, arjohuntleigh representatives have been asked by the facility to show how the procedure of the cpr look like, which was done, following the guidance provided in the product instruction for use.

• 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: 5155847
• MDR Text Key: 28499916
• Report Number: 3007420694-2015-00198
• 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: 10/16/2015,09/16/2015

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: No Information
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Distributor Facility Aware Date: 09/16/2015
• Event Location: Other
• 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?: Yes
• 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): Death
• Patient Age: 20 YR
• Patient Weight: 145