MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE; IKZ

Device Problems No Display/Image (1183); Difficult To Position (1467); Device Operational Issue (2914)

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

Event Date 07/05/2016

Event Type  Death  

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 kinetics concept inc (under registration # (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).The rotoprone bed involved in the event has been quarantined and its inspection is being scheduled.During the initial phase of the investigation, we have found the report of the phone call from (b)(6) hospital documented as patched to rn, the l.I.N.C.(learn.Initiate.Navigate.Connect.) clinician on call.According to that report, the facility staff followed instructions to manually reset the rotoprone and had lost power during that process.They finished supining the patient manually and the patient coded once they were in fully supine position.The patient was resuscitated and the power was returned to the bed.At the time, they contact arjohuntleigh.The arjohuntleigh representative went through the steps with the staff and confirmed the bed has been reset and safe for use.The order for service technician to check the bed in the morning was placed.The arjohuntleigh clinician informed the staff that should there be any additional problems to contact l.I.N.C again; no phone calls were recorded after that.Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2016 arjohuntleigh received a call from (b)(6) hospital in (b)(6) that the rotoprone bed failed during use with patient.Around midnight, the screen went black when the patient was actively coding, at that time.According to the calling nurse, they were not able to reach anyone from technical assistance until the next day.We have been informed that the involved patient expired.

Manufacturer Narrative

(b)(4).On (b)(6) 2016 arjohuntleigh received a call from (b)(6) that the rotoprone bed failed during use with patient.Initial allegation was that, the screen went black when the patient was actively coding, at that time.The facility indicated that they were not able to reach anyone from arjohuntleigh technical assistance until the next day.The patient passed away in the early morning hours of (b)(6).Based on the information collected to date, the provided problem description and the inspection of the device, we have been able to clarify that: when the event occurred the device failed to meet its specification (screen went black, bed remained in a high reverse trendelenburg position, unintended movement to prone instead of supine position), however during device evaluation we were not able to recreate the malfunction claimed by the facility - our evaluation of the device has not revealed any anomalies.The screen, cpr button, rotation feature, bed positioning were found to be working as intended.- during quality control the connector on cable to the cpr red led was found damaged.Also, when the bed was raised slightly, it drifted, but when it was set to rotation it did not move, it stayed at a selected degree - these issues, however, do not influence the bed operation in a way that is relevant to what the facility experienced.When power was on, the message 360 degree was displayed suggesting that the surface was over rotated, for transparency we share in this report that the bed which is a rental device underwent a change on the product labeling, ifu, and user interface prior to placement at the facility.As a result of this change it is indicated there is 24 hour support for rotoprone customer calls.However the allegation that the staff could not reach a technician for assistance, could not be confirmed.The facility call has been registered by the linc system which indicates that there actually was contact between the facility and arjohuntleigh, also, the facility stated that they were instructed by a technician to perform a corrective action such as resetting the bed manually.In summary, the rotoprone bed was used for patient treatment at the time of event occurrence and thus played a role in the incident.However after the comprehensive evaluation it was found that the bed was up to its specification, no malfunction of the device was observed that could have played a role in the cause for the event.The event described by the facility could not be duplicated during bed evaluation.Please note, that we report this event due to the patient outcome while using our device and not due to the device failure or lack of immediate support from the customer supporting team.Additional information will be provided upon conclusion of the manufacturer's investigation.

Manufacturer Narrative

(b)(4).In the course of the investigation we have been able to established following additional information: the investigation has shown that, relating to the nurse's allegation that when pressing the cpr button the bed rotated into prone instead of supine position: should the nurse have pressed the automatic cpr button, rotation would have been towards the most desired position per design - which might have been unexpected and seen by the nursing staff as rotating in a wrong way.The bed is designed to rotate back in the same direction it came from, thus when the surface was over rotated (360°), the bed would be trying to correct the position by rotating back in a proper direction (to prone and further to supine).Also, the nurse stated that, the bed remained in high reverse-trendelenburg position.The emergency release handle will supine the patient surface but it does not return the patient surface to its lowest position.The patient surface will return to its lowest position and rotate to the supine position when the cpr on the user interface of foot end plastic is depressed.This is clearly stated in the user manual.We have not received, despite our effort, additional information regarding whether the event actually caused or contributed to the patient's death.In summary, the event described by the facility could not be duplicated during bed evaluation, thus it seems most likely that during patient coding, the staff, confused with the situation, handled the bed improperly, and in doing so multiplied further issues.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; arjohuntleigh inc.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; arjohuntleigh inc.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5778410
• MDR Text Key: 49049261
• Report Number: 3007420694-2016-00123
• 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: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2016,07/05/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2016
• Distributor Facility Aware Date: 07/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2016
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2016; 09/13/2016
• 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