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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/22/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The product was quarantined and awaiting for evaluation.Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2016 arjohuntleigh clinical consultant received a phone call from registered nurse at (b)(6) to get support in operating the rotoprone bed.The nurse said that in the process of going from supine to prone position, the bed stopped in mid-turn and wouldn't allow to go further alarming that the hatch was opened.The clinical consultant advised to rotate back to supine position, tighten all hatches, then reattempt to prone the patient; that worked and the patient was successfully positioned in prone, no phone call from facility were recorded after that.The next day ((b)(6) 2016) arjohuntleigh have been contacted to pick up the bed when the arjohuntleigh service consultant was notified that the night before, the facility reported issues with the bed during patient coding.The nurse said that when the used the cpr button the bed only turned half way and they had to finish the bed turning manually (as per the instruction for use).The patient passed away on (b)(6) 2016.

Manufacturer Narrative

(b)(4).On (b)(6) 2016 arjohuntleigh clinical consultant received a phone call from registered nurse at regional medical center bayonet pion to get support in operating the roto-prone bed.The nurse said that in the process of going from supine to prone position, the bed stopped in mid-turn and would not allow to go further alarming that the hatch was opened.Arjohuntleigh clinical consultant advised to rotate the bed back to supine position, tighten all hatches, then reattempt to prone the patient.That worked and the patient was successfully positioned in prone; no phone call from facility were recorded after that.The next day ((b)(6)2016) arjohuntleigh has been contacted to pick up the bed.During collecting the bed, the arjohuntleigh service consultant was notified that the night before, the facility reported issues with the bed during patient coding.The nurse said that when they used the cpr button, the bed only turned half way and they had to finish the bed turning manually (as per the instruction for use).Eventually, the patient passed away on (b)(6) 2016.The bed was returned to service center for further device evaluation by the sustaining engineer on (b)(6) 2016 through (b)(6) 2016.The evaluation revealed the following: visual inspection has not revealed any obvious damage to the unit, hinges, lock pins, rotation handle, switch plates or lower hatch that could have given a false alarm.No indication of misuse or misalignment of the hatch or hatch stops was found.Hatch was verified against the amount of force needed to close both pins.In each case the lower hatch closed properly with minimal force required.It was found that one pin did not always slide in correctly.However considering the indication that the facility staff was able to turn the bed to supine manually and as a result patient did not become unsecured at that pin or fall, it is concluded that the pin was not malfunctioning at the time and did not play a role in the cause of the event.Please note, that roto-prone is equipped with four hatches on the bottom of the patient surface that allow access to the patient when the patient is in the prone position.In order to turn the bed surface from prone to supine position hatches must be securely locked.In case the one of the hatches is not closed the system will sense an unsafe operating condition and will prevent further rotation and alarm visually (error displayed on the bed screen indicating which hatch is open) and audibly will occur.The system senses open hatch, activating the 'hatch open alarm'.If door hatches are not securely closed, system will not allow the bed to be rotated minimizing unintentional fall from the bed.In this situation safety feature works as designed.Roto-prone device is equipped in two separate, independent systems allowing device rotation: an automatic, electrical rotation and a mechanical, manual rotation.Please note, that in case of emergency situation and e.G.Failure of the electrical system, the bed manual rotation feature will override all electrically driven functions and allow to provide the manual rotation to get the patient either in supine or prone position as required per clinical assessment.According to information collected for this event, the hospital staff eventually rotated the bed manually as per the instruction for use.In summary, the roto-prone 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 safety features designed in the device worked as intended.We report this event due to the patient outcome while using our device.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; , tx 78219, u; 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: 5768637
• MDR Text Key: 48725474
• Report Number: 3007420694-2016-00120
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/05/2016,06/22/2016

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
• 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: 08/05/2016
• Distributor Facility Aware Date: 06/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• 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