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

Model Number FX811B3B4AMABB

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The device was inspected by an arjo technician.The device evaluation revealed that the side rail was bent, however the side rail was functioning properly (the side rail could be locked and lower without any issue).There was no malfunction noticed with the bed exit alarm.The bed exit alarm wasn¿t set because the bed frame was operating only on battery power.The exit alarm detects patient¿s movements, however it will not restrain patient from leaving the bed.The instruction for use for citadel plus bed frame (document number: (b)(4)) includes below information: "make sure that battery is kept fully charged (.) the bed should be connected to the electricitysupply at all times during normal use".To sum up, the device had no malfunction that caused the patient¿s fall.As the event was unwitnessed and the patient was not able to explain the fall, the clear scenario of the patient's fall remains unknown.The exact cause is not possible to be identified.To sum up, the arjo device was used for patient treatment when the event occurred, and from that perspective, it played a role in the event.During the bed frame evaluation, the side rail was bent, and the device did not meet its specifications.This complaint is reportable due to the allegation of the patient's fall from the bed.

Manufacturer Narrative

The investigation is ongoing.The results will be provided in the final report.

Event Description

It was claimed that the patient fell out from the bed frame.The event was unwitnessed, the patient was found on floor.Allegedly, the patient was attempting to use the restroom from the bed itself.No injury was reported.During interview with the customer.The bed exit alarm wasn¿t set because the frame was only operating on battery power and was not connected to th outlet.The staff had no idea that the frame was not connected to the outlet.

• 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: 19178573
• MDR Text Key: 341608685
• Report Number: 3007420694-2024-00112
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220331
• 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,Followup
• Report Date: 04/30/2024

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: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Weight: 127 KG