MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O CITADEL PLUS BARIATRIC BED FRAME SYSTEM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the manufacturer's investigation.Root cause investigation is ongoing.The following conclusions has been made as an effect of the progressing work: at least two beds have exhibited the following behavior; when the left handle trigger is being pressed, and the speed throttle on the right handle is let go, the bed continues to move as if the right hand throttle was still being activated.The bed is taken out of this state by pressing the reset button on the powerdrive control board.The bed does not move if the left hand trigger is not being pressed.In other words, this does not happen when the bed is unattended.Static checks (wire inspection and voltage measurements) of at least one bed yielded expected operation.Additional diagnostic equipment was sent to service technicians that are working with r&d team to gather diagnostic data.On several occasions, this issue was seen when going up a steep ramp.The issue is now investigated further to find exact root cause of the problem.

Event Description

On 2016-12-21 arjohuntleigh received complaint where it was reported that while testing the bed in the depot and when the powerdrive was engaged - the bed drove itself forwards without engaging any of the controls.The complaint was deemed reportable due to the device malfunction.

Manufacturer Narrative

(b)(4).On 2016-12-21 arjohuntleigh received a complaint were it was found that during testing the bed, when the powerdrive was engaged the bed drove itself forwards - without engaging any of the controls.Complaints review revealed that there is slight rising trend for the problem with uncommanded movement from powerdrive system observed.The performed risk analysis review revealed that the dfmeca for citadel plus contains a hazard that reflects the situation described in the complaint and considers it as acceptable.While using the power drive system if the bed is driving forward and runs into heavy resistance it gets into a state where the power drive system will not be able to drive forward, it will not respond to joystick input forward or backward, and the motor will produce a continuous rattling noise.Examples of heavy resistance include having the bed frame dragging on a surface (such as at the top of a steep ramp), or having an obstruction in front of the wheels that prevent them from moving forward.This condition is reached as a result of the power drive system detecting an overcurrent condition on the motor and the rattling is caused by the system rapidly cycling the motor on and off.When the left trigger is released the rapid cycling will stop, however every subsequent time the trigger is pressed the rapid cycling will occur and the power drive system will not respond to joystick input.This condition can be cleared if the power drive system is reset due to the battery running out or if a manual reset is performed.We conclude that the cause of the failure is a design issue related to software.In summary, the device was not being used with patient at the time of the event.Despite that the event did not result in serious injury to patient, the complaint is considered reportable due to a technical malfunction that led to uncommanded movement of the device.Such situation might possibly possible pose a risk to the patients health.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh (b)(4).(registration # 3007420694) on behalf of the importer arjohuntleigh, inc.(ahus) (registration # 1419652).This is a follow up report to the final report sent on 2017-01-19.After reviewing health hazard evaluation (hhe) concerning uncommanded power drive movement it was established that this kind of failure may result only in customer annoyance which has an occurrence of 'rare' (unlikely; feasible, but unlikely in common use) and a severity of 'none' (no adverse health consequence.Could cause minor nuisance or inconvenience to end user).Because of the low risk to health we no longer see uncommanded power drive movement reportable to the competent authorities.Moreover it needs to be emphasized that the overall hhe assessment shows that addressing the product performance through a design change/software update may reduce the occurrence of customer annoyance.To ensure the safety operation of power drive system the instruction for use provided together with the involved device (831.374 rev.B) includes information regarding the possibility of avoiding the overcurrent of the power drive system: warning: "when operating on slopes, always use slow speed.Do not operate on slopes in excess of >7 degree".Based on above we conclude that the cause of the failure is both the device being moved over the slope in excess of 7 degrees against recommendations in product instruction from use and software bug which does not protect the device from moving with only left hand trigger being pressed.

• Brand Name: CITADEL PLUS BARIATRIC BED FRAME SYSTEM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6202034
• MDR Text Key: 63264634
• Report Number: 3007420694-2016-00263
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2017
• Distributor Facility Aware Date: 12/05/2016
• Event Location: Other
• Date Report to Manufacturer: 07/20/2017
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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