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

On (b)(6) 2017 arjohuntleigh was notified about a complaint involving citadel bed.Following information provided the radius arm became dislodged from the sub frame leading to bed's collapse.The above failure was identified by arjohuntleigh representative during the quality check after rental period.There was no injury sustained.

Manufacturer Narrative

This report is being filed under exemption e2012070 (b)(4).On 2017-dec-07 arjohuntleigh was notified about a complaint involving citadel bed.Following information provided the radius arm became dislodged from the sub frame leading to bed's collapse.The above failure was identified by arjohuntleigh representative during the quality check after rental period.As a consequence there was no injury sustained.At the time of device inspection, it was observed also that the foot end slide block was cracked, foot end actuator was bent and skin iq cable was cut.The slide block and actuator malfunction the most likely occurred after bed's collapse, as a consequence of radius arm detachment.The skin iq cable failure does not influence bed's stability therefore was ruled out to be the cause of reported issue.Based on above, we conclude that none of the malfunctions mentioned above contributed to the issue occurrence.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 therefore the manufacturing error can be precluded.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.It needs to be emphasized that the malfunction in question has not been reported before by the customer what would suggest that the bed was working as intended while being in use with patient.As per arjohuntleigh technician the radius arm could detach during the return trip from the customer facility, however despite out best efforts it was not confirmed in which way the asset was secured in transport.Based on the comprehensive analysis performed we conclude that external force applied on the bed during transport could be a contributing factor to the bed's collapse, however due to the lack of sufficient information the exact cause of the issue investigated here could not be identified with certainty.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 malfunction occurrence.At the time of bed's collapse the device was not used for patient's handling.Upon the conducted investigation and bed's inspection done by the arjohuntleigh representative, we were unable to determine the exact cause of the issue occurrence.The device was reported to collapse and from that perspective, the citadel bed did not meet its manufacturer's specification.

Manufacturer Narrative

Missing udi number was added.

• 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: 7163455
• MDR Text Key: 96840098
• Report Number: 3007420694-2018-00004
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2018,02/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• 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: 04/24/2018
• Distributor Facility Aware Date: 12/07/2017
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 04/24/2018
• Date Manufacturer Received: 12/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other