MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP.Z O.O. 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

Arjohuntleigh was notified about a complaint involving citadel bed.Following information provided the radius arm became dislodged from the sub frame.There was no indication of patient's involvement and no injury was reported.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).On (b)(6) 2018 arjo was notified about a complaint involving citadel bed.Following the information provided, the radius arm dislodged from bed's frame.The malfunction was noticed at the customer site.At that time there was a patient lying on the bed, no injury nor other medical consequences were reported.After the bed arrived to the service center for a repair, it was confirmed by arjo technician that one of the c-clips (securing radius arm) was missing.It needs to be emphasized that each rental device before being released for next rent must pass a quality control check.One of steps of quality check is to verify if bed's raising and lowering functions to which radius arm is used for are working as intended.The device in question passed pre-use quality check successfully.According to the information provided by service technician if the c-clip would have been missing during pre-use a quality check or during transporting and installation process it would have been easily noticed.When the c-clip is missing the frame does not raise or lower properly, and may collapse.The technician confirmed also that the c-clip could pop off as a result of force triggered by radius arm detachment.In arjo technician's opinion the bed was subjected to some kind of impact that caused the damage.In a course of the investigation we were able to establish that the radius arm detachment occurred at the customer site before the device was being transported to the service center for a repair.However as the circumstances of the malfunction remain unknown we were not in a position to identify the exact cause of failure occurrence.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 en 60601-2-52.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 malfunction itself suggests that the bed was a subject to abuse and enormous external forces what in consequences led to the radius arm detachment.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 a patient at the time the actual malfunction was noticed.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 SP.Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7424414
• MDR Text Key: 105690723
• Report Number: 3007420694-2018-00088
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• 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: 06/04/2018
• Distributor Facility Aware Date: 03/14/2018
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 06/04/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other