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 05/22/2023

Event Type  malfunction  

Event Description

Arjo became aware of the event involving the citadel plus bed frame.The customer staff reported that the patient fell from the bed.The event occurred when the patient was trying to exit the bed.The side rail was loaded by the patient and broke during the event.No injury occurred.

Manufacturer Narrative

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 detachment might be related to an excessive force applied to the side rail.This is in line with the side rail condition (it was mechanically damaged) and the circumstances in which the event occurred.The side rail was loaded by the patient who tried to get up from the bed.Based on the photographic evidence provided, the side rail panel was partially detached from the metal plate to which the side rail is assembled (2 of 4 screws holding it were ripped off).The instruction for use for citadel plus bed frame (document number: 831.374_en) includes the following warnings: ¿side rails are not intended to restrain patients who make a deliberate attempt to exit the bed.¿ "the caregiver should always aid patient in exiting the bed." ifu includes also information that 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.Arjo device failed to meet its performance specification since the side rail was partially detached.The bed frame was in use at that time.The complaint decided to be reportable due to patient¿s fall.Allegedly, the side rail was detached at that time.No injury was claimed.

• 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: 17124728
• MDR Text Key: 317138890
• Report Number: 3007420694-2023-00137
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200731
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• 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