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

Model Number FX811B3B4AMABB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo became aware of the event involving a citadel plus bed frame.A patient fell from the bed.No injury occurred.Clarification of the event circumstances is ongoing, at this time it is unknown if the side rails were locked in the up position at the time of the event.The photographic evidence provided revealed that the side rail panel was partially detached from the bed.

Manufacturer Narrative

Based on the collected information and circumstance in which the claimed issue occurred, it seems most probable that the side rail was damaged by the patient who leaned on it.The loss of the side rail functionality resulted in the patient falling from the bed.According to the instruction for use for citadel plus bed (ifu, 831.374 rev.I), ¿the clinically qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails.¿ ¿to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended.¿ to sum up, based on the analysis of the complaints and the analysis carried out by the manufacturer, the external excessive force must first compromise the integrity of the safety side prior to breaking it.Arjo device failed to meet its performance specification since the side rail was partially detached.The device was in use at that time, the patient fell from the bed.This claim was assessed as reportable due to the patient's fall from the bed even no injury was reported.

Event Description

Arjo became aware of the event involving a citadel plus bed frame.A patient fell from the bed.The side rail was locked in the up position at the time of the event.No injury occurred.The photographic evidence provided revealed that the side rail panel was partially detached from the bed.2 of the 4 screws holding it were ripped off.

• 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: 18117732
• MDR Text Key: 327882794
• Report Number: 3007420694-2023-00271
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)210723
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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 Weight: 204 KG