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

Model Number	CX812A3K1AMAD0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the information gathered, the patient fell from the citadel bed.The customer alleged that the citadel bed exit alarm was set, but did not turn on when the event occurred.The exit alarm is designed to notify the staff when the patient¿s undesired movement occurs.It does not protect the patient from intentional or unintentional exit from the bed.The arjo service technician checked the exit alarm and no issue was found.The circumstances of the event remain unknown as the event was unwitnessed.There was no injury reported by a customer.Based on the quality check performed after returning the device from the customer, no device failure was observed.The allegation concerning exit alarm failure was not confirmed as it was working properly during testing.The circumstances of the event remain unknown as the event was unwitnessed.It is unknown whether the side rails were raised when the event occurred.The instructions for use for citadel bed frame (830.213-en rev.12) informs user: "the patient movement detection function should be checked periodically for correct operation and before each new patient uses the bed¿ ¿before using patient movement detection, verify that the alarm can be easily heard by caregivers.Example; at the nurse¿s station.¿ the ifu describes also the potential risk of patient's fall inadvertent exit on several occasions: "to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and or family." to sum up, arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.It was claimed that the exit alarm did not work, however no malfunction was found during the device evaluation.This complaint is reportable due to allegation of patient's fall from the bed.
Event or Problem Description
Following the information gathered, the patient fell from the citadel bed.The customer alleged that the citadel bed exit alarm was set, but did not turn on when the event occurred.The exit alarm is designed to notify the staff when the patient¿s undesired movement occurs.It does not protect the patient from intentional or unintentional exit from the bed.The arjo service technician checked the exit alarm and no issue was found.The circumstances of the event remain unknown as the event was unwitnessed.There was no injury reported by a customer.

• Brand Name: CITADEL BED FRAME
• Common Device Name: 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: 19095439
• Report Number: 3007420694-2024-00102
• Device Sequence Number: 15379851
• Product Code: FNL
• UDI-Device Identifier: 05056097351742
• UDI-Public: (01)05056097351742(11)210407
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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 Model Number: CX812A3K1AMAD0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown