MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FXX21C4B1AAABB

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Arjo became aware of a citadel plus bed frame malfunction.The side rail, hinges and extension frame were broken.The customer explained that the damage of bed frame occurred due to hit in the doorway at time of bed¿s transport.The bed was is use on that time.No injury was claimed.

Manufacturer Narrative

Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

It was claimed by the customer staff that during the citadel plus bed frame relocation from one ward to another, the bed hit the door frame and was damaged.The bed was in use by a patient at that time.No injury was claimed.When the arjo technician arrived at the customer facility the bed frame was still in use, therefore, no full evaluation could be conducted and only photos were taken.The technician initially assessed that the side rail, hinges, and extension frame were broken.After the patient¿s transfer to another bed frame, the citadel plus was quarantined and collected from the customer by arjo for repair.The bed was repaired by replacement of two side rails, side rail¿s mechanism and side extension frame.The parts were damaged and bent but no detachment occurred.Additionally, the technician replaced the junction box and power drive handle.The instruction for use for citadel plus bed frame (document number: 831.374_en) includes preventive maintenance procedures for side rails: the operation of the side rails should be checked daily by the device owner.If the malfunction is identified, arjo or approved service agent should be contacted.In summary, the complaint was initially assessed as reportable due to the suspicion that the side rail was detached from the side rail mechanism.In the course of the investigation, proved to be erroneous.The side rail panel was only bent, no detachment occurred.The customer staff followed the instruction for use and requested arjo service when the bed frame was damaged.The bed frame was excluded from use and quarantined.The reported issue was deemed not to meet vigilance criteria.The bed frame damage did not result in death or a serious deterioration in state of health and is unlikely to lead to a death or serious deterioration in state of health in the future.Taking all the facts into account, this complaint is deemed not reportable to competent authority.Arjo will not be reporting future complaints of this type.However, arjo will continue monitoring the complaints and report any events in which death and/or serious injury occurred that arjo device contributed to.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15860427
• MDR Text Key: 307998462
• Report Number: 3007420694-2022-00192
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 050559852756815
• UDI-Public: (01)050559852756815(11)180125
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FXX21C4B1AAABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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