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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2016 arjohuntleigh received a complaint where it was stated that the bed is going forward just by holding the right hand trigger.Releasing this trigger will not stop the forward movement instantly.It was stated that the further the bed drives the longer it will take to stop.Both triggers were clicking properly and connections are good.Further evaluation revealed that normal bed is stopping instantly when controls are released.The defective bed moves forward just by engaging the right hand trigger.Complaint is deemed reportable due to the malfunction of the device.

Manufacturer Narrative

(b)(4).Arjohuntleigh is still in process of gathering additional information and performing root cause investigation.The conclusions will be provided upon the manufacturers investigation completion.

Event Description

On (b)(6) 2016 arjohuntleigh received a complaint where it was stated that the bed is going forward just by holding the right hand trigger.Releasing this trigger will not stop the forward movement instantly.It was stated that the further the bed drives the longer it will take to stop.Both triggers were clicking properly and connections are good.Further evaluation revealed that normal bed is stopping instantly when controls are released whereas the defective bed has a time lag.Bed was inspected and was confirmed to be in good condition without scratches or dents.Function test results show that driving mechanism was not functioning properly - left hand side trigger was not functioning.

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the manufacturer's investigation.On 03-06-2017 arjohuntleigh was informed that service technician has scheduled a visit to repair the unit this week.After the repair faulty parts will be returned from market for further evaluation.

Manufacturer Narrative

(b)(4).The citadel plus bariatric care system is intended for the acute and post-acute care environments.It is indicated for medical purposes to aid the patient and stuff during the performance of routine care.Each citadel plus bed is equipped with power drive system designed to provide powered transport for the citadel plus bariatric bed frame system.This power drive system feature is responsible for activating forward and backward movement of the device.Left and right hand steering are controlled by the user, have to be applied at the same time.Left hand trigger must be held down during entire duration of power drive operation.Right hand trigger is used to give direction to movement (forward or backwards).Releasing left hand trigger will apply the power drive brake and make the power drive inoperable.On (b)(6) 2016 arjohuntleigh has received a customer complaint involving citadel plus bed (serial number: (b)($)).The reported malfunction took place in the (b)(6) hospital in (b)(6).The customer allegation was that bed is moving forward without two power drive handles being activated.There was no resident's fall nor injury reported.After the event, the device was moved through the arjohuntleigh inspection where it was revealed that the bed is going forward by just holding the right hand trigger without using left hand trigger and keeps going forward even when releasing the right handle.Additionally it was indicated that the further the bed drives the longer it takes to stop the device from moving.The bed was in overall good condition while the incident occurred, neither scratches nor dents were found within bed.During further investigation the technician found out that the source of claimed malfunction is associated with pinched left hand power drive extension cable (b)(4).Power drive extension cables are routed on both sides of the bed from the head ends and clamped around the handle on which the transport screw is located using cable ties.Based on the collected information, photographic evidence and findings made during part inspection it appears possible that operator pinched the cable while tightening the screw as the cable was mechanically damaged in place the transport bolt is fitted.As a corrective action, the faulty part was replaced and the device was reported to work as per manufacturer specification.The device was released for customer use.As a result of our findings, and the likeliness that the issue was caused by manufacturer man error an awareness was issued on production line (dated on 2017-03-31) to pay attention to correct assembly of transport bolts that may pinch power drive extension cables while incorrectly tighten.It needs to be emphasized that the likelihood of the occurrence of the death or serious injury in case of unintended bed movement is remote.In addition, the movement range is always within the predetermined and safe operating range of the device.In addition, the device instruction for use (831.374 rev.B) that was provided together with citadel plus device warns the user how to operate the device safely.In summary, although in the investigated complaint there was no adverse outcome, we determined to view this complaint as reportable in the abundance of caution.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine the exact root cause of claimed failure which was defined to be associated with pinched left hand power drive extension cable (b)(4) as a result of manufacturer man error.When reviewing similar reportable events recorded with awareness date from 14-oct-2015 (1st complaint registered in (b)(6) for citadel plus bed) till 30-mar-2017, a limited number of cases with similar fault description (power drive- uncommanded bed movement) were found.With amount of sold devices on the market, the complaint ratio for reportable complaints with this failure mode is considered to be low.Arjohuntleigh devices played a role in the event, as it was used for the patient treatment when the event occurred and it has failed to meet manufacturer specifications.

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 2017-06-04.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 (symptom: bed is moving with only one power drive handle engaged) reportable to the competent authorities.

• 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: 6236358
• MDR Text Key: 64439164
• Report Number: 3007420694-2017-00005
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: 12/19/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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