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

Model Number CX711A2F2AMAB0

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

On (b)(6) 2017 arjohuntleigh was notified about a complaint involving citadel bed.According to customer's allegation the frame was twisted and leaning with patient on unit.After malfunction detection the bed was quarantined and taken to service center for repair.During the quality check conducted in service center the radius arm became dislodged from the sub frame causing bed's collapse.As a consequence there was no injury sustained.

Manufacturer Narrative

This report is being filed under exemption e2012070 (b)(4).On 2017-12-08 arjohuntleigh was notified about a complaint involving citadel bed.The all facts gathered allowed us to establish the following sequence of events.The bed was sent to the customer facility for the rental period.The customer unpacked the bed and put it into service.After the patient was placed on the device the bed frame was found to be "twisted and leaning".The patient did not sustain any injuries.It needs to be emphasized that the device involved in the event is part of arjohuntleigh us rental fleet.Each rental device before being release for next rent must pass a quality control check.It confirms that before bed's delivery to the customer the citadel bed was working as intended and the malfunction (bent of bed frame) occurred on the way from service center to the customer.As an immediate action, the bed was quarantined and sent to the service center for the inspection and repair.Upon device arrival to the service center the arjohuntleigh technician performed a troubleshooting of reported bed.While doing this he witnessed bed's collapse.According to the photographic evidence provided the bed collapsed due to radius arm became dislodged from the sub frame.The c-clip which is intended to secure radius arm was still present.As the complete radius arm detachment occurred after sending the bed back to the service center for the repair it might be assumed that the external force applied on the bed during transport in conjunction with earlier defects (bent of the frame) could be the cause of radius arm detachment.However despite our best effort, it was not confirmed by the service technician how the asset was secured in transport it needs to be pointed out 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 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.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the bed's collapse and the fact that the bed was in use with patient before the actual collapse occurred.At the time of bed's collapse the device was not being used for patient's handling.The device was reported to collapse 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: 7166927
• MDR Text Key: 96852428
• Report Number: 3007420694-2018-00005
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: CX711A2F2AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Distributor Facility Aware Date: 12/08/2017
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other