MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA CITADEL PATIENT CARE SYSTEM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number CX811A3F3AMAB0

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provide within the complaint the radius arm detached from bed's frame.There was no injury sustained in relation to this malfunction.The issue was discovered by arjohuntleigh service technician during quality check after rental period.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).The investigation is still in progress.Additional information will be provided upon conclusion of the manufacturer's investigation.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration# (b)(4)) on behalf of the importer (b)(4) (registration# (b)(4)).On 2018-03-08 arjo was notified about a complaint involving citadel bed.Following the information provided the head end radius arm dislodged from bed's frame.The main consequence was that the head end radius arm did no raise evenly with the foot end radius arm.The malfunction was noticed in service center by arjo technician while conducting quality check after rental period.There was no patient involved, no injury nor other medical consequences were reported.It needs to be emphasized that the device involved in the event is part of arjo us rental fleet.Each rental device before being release for next rent must pass a quality control check.In this particular case the pre use check dated on 2017-nov-30 confirmed that the device was in general good working condition before it was sent to the customer.From a design perspective the radius arm may detach if the c-clip securing radius arm is missing or if the device is a subject of external force being applied.In this particular case the c-clip was present at the time the malfunction occurred therefore this cause may be ruled out.Following arjo technician's opinion the malfunction probably took place during transport.However this statement could not confirm it with certainty due to the fact it remind unknown how the asset was secured while being transported and if the damage was present before transporting the bed back to service center.It needs to be emphasized that all manufactured citadel beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found.It is also worth noting that the citadel bed has been designed, produced and certified to meet the requirements of standard (b)(4).The citadel beds are passing the requirements of clauses: 201.9.4.2.3 - instability from horizontal and vertical forces, 201.9.8.3.1 - safe working load, 201.9.8.3.2 - static forces due to loading from persons or 201.9.8.3.3.1 dynamic forces due to sitting down.This confirms that the beds are stable devices which are not falling apart during usage accordingly to product instruction for use.Summarizing, the information provided within the complaint record suggest that the bed was a subject to abuse and enormous external forces what in consequences led to the malfunction occurrence.However due to the lack of sufficient information the exact cause of the issue investigated here could not be identified with a certainty.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the radius arm detachment and the fact that the bed was in use with patient before the actual failure was identified.At the time of the malfunction occurrence the device was not being used for patient's handling.The radius arm detached from bed's frame and from that perspective, the citadel bed did not meet its manufacturer's specification.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7402051
• MDR Text Key: 104536893
• Report Number: 3007420694-2018-00081
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2018
• Distributor Facility Aware Date: 03/08/2018
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 05/16/2018
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other