MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. A GETINGE GROUP CO ROTOPRONE 24; ROTATIONAL ELECTRIC BED

Model Number 209500

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/15/2015

Event Type  Death  

Event Description

Patient was admitted to the medical icu on (b)(6) 2015 from an outside hospital.Patient was critically ill and transported via air ambulance in the prone position.Patient was transferred to a rotoprone-24 bed on the evening of (b)(6) 2015.On (b)(6) 2015 at approximately 0720, the patient's hr fell (patient was first in a brady rhythm, then eventually asystole) and staff immediately initiated the process for turning the bed to a supine position to begin cpr.During this process, staff received multiple "bottom hatch not closed" alerts, and each time the alert notification occurred, the bed stopped rotating.In several attempts to get the bed to complete its rotation, the physician and rn exerted additional force on the hatch (which was verified to be closed) which allowed the bed to briefly continue rotation.After approximately 4 and a half minutes of stops/ starts, the bed completed rotation to the supine position.In addition, staff reported 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 for cpr.Once the patient was in position for cpr, chest compressions were initiated and the code lasted approximately one hour, when the decision was made to stop cpr.The patient was not able to be resuscitated.The bed was sequestered and tested by clinical engineering and the vendor ((b)(4)).Initial inspection revealed the two release ties for the emergency manual release door and lever were still intact.During the incident, rather than use the emergency manual release, the clinical staff chose to use the electronic cpr process to bring the patient back to a supine position.Staff felt the cpr electronic process better ensured patient safety because it requires that all door hatches and strap mechanisms be securely fastened before rotating the patient, while the emergency release mechanism does not.During post-incident testing, the bed rotated without any errors or alerts.The process to prepare and rotate the bed took approximately three minutes.The rotation mechanism, sensors, and alarms were tested and all appeared to be working properly.It was noted by clinical engineering that the sensors did appear to be sensitive to the amount of force being applied, and the bed alerted (and stopped rotation) when the force was not high enough (e.G.Straps not tight enough), even when the hatch or belt appeared to be engaged.Note: post-incident testing was done without a patient in the bed and the patient's weight was (b)(6).(bed maximum is 350 lbs.).It is possible that during rotation, the patient may have shifted such that the sensor mechanism disengaged just enough to activate the alert and stop rotation.Finally, nursing staff in the unit (including the rn assigned to ths patient) received a four-hour training and in-service from the vendor on this bed just three weeks prior to the incident.We do not believe that use-error played a role in this incident.

• Brand Name: ROTOPRONE 24
• Type of Device: ROTATIONAL ELECTRIC BED
• Manufacturer (Section D): ARJOHUNTLEIGH INC. A GETINGE GROUP CO; addison IL
• MDR Report Key: 5130884
• MDR Text Key: 27623883
• Report Number: 5130884
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2015
• Distributor Facility Aware Date: 09/15/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 YR
• Patient Weight: 145