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

Model Number FXX21C4D4AMBBB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 06/24/2023

Event Type  malfunction  

Event Description

The patient in delirium was found on the floor by the nursing staff.Allegedly, the patient broke the side rail and fell out of the citadel plus bed.No injury occurred.Based on the collected information, the event was unwitnessed.The photographic evidence provided confirmed the bed malfunction.The side rail panel was detached from the side rail mechanism.All screws holding the panel to the metal plate were ripped off.

Manufacturer Narrative

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

Manufacturer Narrative

The patient in delirium was found on the floor by the nursing staff.Allegedly, the patient broke side rail and fell out of the citadel plus bed.No injury occurred.The event was unwitnessed, therefore it is unknown how the patient broke the side rail.The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor which could lead to the side rail damage might be related to an excessive force applied to the side rail.This is in line with the event circumstances and the side rail condition, it was mechanically damaged (the side rail panel was fully detached from the metal plate as all screws holding it were ripped off).According to the instruction for use for citadel plus bed frame (ifu 831.374_en): ¿the clinically qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails.¿ ¿side rails are not intended to restrain patients who make a deliberate attempt to exit the bed.¿ ¿to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended.¿ the ifu includes also 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.Based on the analysis of the complaints concerning side rail detachment, the external excessive force must first compromise the integrity of the safety side prior to breaking it.The side rail was damaged and from that perspective, the citadel plus bed did not meet the performance specification.The device was in use when the event occurred.Although no injury occurred, we report this incident due to the patient¿s fall from the arjo bed frame.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17323213
• MDR Text Key: 319282063
• Report Number: 3007420694-2023-00167
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097319551
• UDI-Public: (01)05056097319551(11)210923
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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 Operator: Other
• Device Model Number: FXX21C4D4AMBBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 06/24/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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 Sex: Male
• Patient Weight: 130 KG