MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/27/2016

Event Type  Injury  

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 kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.The investigation has been performed and the conclusions are as followed: the product involved in the incident is a rotoprone therapy system serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet.The device was rented to the customer (b)(4) university medical center.The customer called for assistance in manually placing the device in supine position.The customer stated that the patient surface was first manually placed in supine position and then in prone.The patient decompensated in supine position to 50%.The nurse stated that the buckle alarm occurred, even though the buckle seemed to be fastened.The buckle alarm will occur if the buckle strap is not secured or if the proning packs are not tight enough to keep the proning arms held tightly against the patient surface during rotation.This alarm is to protect the patient from falling out of the bed or migrating during rotation.The rotoprone device is equipped with two independent systems allowing for the patient surface to rotate, automatic electrical rotation and manual rotation.Even in case of buckle alarm the device can be still operated and if needed patient surface may be placed in prone or supine position.Further information provided by the arjohuntleigh clinical educator was that the drop in oxygenation level was related rather to placing the patient to supine than to alarm condition.The alarm was overridden with use of manual rotation lever which allowed to put the patient surface in desire position.An arjohuntleigh representative (clinical consultant critical care), who went to the facility to assist in person, reported that when arrived to the facility the patient was in supine position and stable, the saturation level was within normal limits.The nurse verbalized that they were not having any issues with the bed.The clinical consultant educated the facility of the device operation, explaining the reason for buckle alarm occurrence and how to resolve the issue if reoccurs.User manual #208662-ah rev.D, which is delivered to the customer together with the bed, provides guidance how to correct the buckle alarm condition, also the information regarding which buckle needs tightening and what steps need to be performed are displayed on the bed screen.The user manual contains specific instructions on how to use the powered cpr function and the emergency release handle.The emergency release feature disarms all safety alarms.Also in section 'safety information' of the rotoprone's 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".In arjohuntleigh investigation it seems that the buckle alarm occurrence was related to the insufficient tightening of the buckle straps, which however did not influence patient condition.Desaturation to 50% was related to the caregivers decision to place the patient in supine from unknown reason.For patients with low oxygenation reserves, movement to the supine position can result in a significant physiologic decompensation, regardless of the therapy provided by the rotoprone therapy system.The bed passed manufacturer specification on both occasions pre and post placement in accordance to quality control check.Prior the renting period the device went through the quality control checklist on september 20, 2016, the device met manufacturer specification, all bed functions operated correctly.After the event, the bed was returned to the service centre were was inspected and the only item that required service maintenance was batteries.The repair is not related to the investigated event.No other issues were found.On october 28, 2016 the asset was checked per quality control procedure and no anomalies were recorded, bed was working up to its specification.In summary, the device was being used for treatment at the time of the event and therefore was directly involved in the event.In the course of the investigation it was found that the device was up to manufacturer's specification.The buckle alarm occurred in a result of use error - not sufficient buckle strap tightening.The buckle alarm did not influence patient condition as it was related to the caregivers decision of placing the patient in supine position and not device alarm.We report this incident based on the information that patient desaturated to 50%, which is considered a serious injury and not due to the device malfunction.The rotoprone therapy system worked as intended and help improved the patient condition, when the customer was visited by arjohuntleigh representative, it was reported that the patient was stable and saturation level was within normal limits.Given the circumstances and the fact that the issue was, most likely, related to the limited knowledge of how to operate the device, arjohuntleigh suggests to notify the customer about the offered training for the rotoprone users in order to make the staff more confident while using the bed and to minimize occurrence of similar incidents in the future.Arjohuntleigh shall continue to monitor for any further events of this nature.

Event Description

Arjohuntleigh was informed that the patient decompensated to 50 % in supine position.The staff used manual rotation feature to manually place the patient surface in prone position after it was manually placed in supine position.The information provided was that the device experienced a buckle alarm, even though the buckles seemed to be buckled.The staff called asking for assistance in turning the patient surface back to supine using manual rotation feature.An arjohuntleigh representative (clinical consultant critical care), who went to the facility to assist in person, reported that when arrived to the facility the patient was in supine position and stable, the saturation level was within normal limits.The nurse verbalized that they were not having any issues with the bed.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• 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: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL ; 98282467
• MDR Report Key: 6511010
• MDR Text Key: 73378006
• Report Number: 3007420694-2017-00093
• 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
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2016
• 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): Other