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

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that a patient fell out from a bed.No injury was reported.The facility stated that the exit alarm was not working.After the event the bed was evaluated by arjo technician and no malfunction was found.

Manufacturer Narrative

Following information provided by the facility staff, the side rails were raised when the event occurred, however as per the instructions for use dedicated to citadel bed frame system (830.213-en): "side rails and not intended to restrain patients who make a deliberate attempt to exit the bed".The facility staff mentioned also that the exit alarm did not work despite being activated.During device evaluation, this issue was not recreated.The bed exit alarm was working correctly.The alarm detects the patient's movements.The sensitivity level of the detected patient movement can be adjusted using the controls on the foot end split side rails.Depending on the selected level, it can detect even small movements of the patient in bed or larger ones, such as attempts to get the patient out of bed.The activated exit alarm is intended to inform the facility staff about patient movements but is not responsible for preventing falls.To ensure patient safety, the instructions for use dedicated to citadel bed frame system (830.213-en) warns: "to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." "caregiver should always aid the patient in exiting the bed.Make sure a capable patient knows how to get out of the bed safely." to sum up, no device malfunction was confirmed during the citadel bed frame inspection.The complaint decided to be reportable due to allegation of patient fall.No injury was claimed.

• Brand Name: CITADEL BED FRAME
• 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: 18666146
• MDR Text Key: 335833197
• Report Number: 3007420694-2024-00033
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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