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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

An arjo representative observed at the time of pick-up the citadel plus bed frame that one of the side rails was broken off the bed.The interviewed nurse explained that the damage occurred at the time of use the bed by a patient.No injury was claimed.

Manufacturer Narrative

An arjo representative observed at the time of pick-up the citadel plus bed frame that one of the side rails was broken off the bed.The interviewed nurse explained that the damage occurred at the time of use the bed by a patient.No injury was claimed.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 event description - the patient shifted all of their weight on the side rail that was up.The photographic evidence revealed that the side rail panel was mechanically damaged, it was detached from the side rail mechanism (the screws holding the panel were ripped off).The instruction for use for citadel plus bed frame (document number: (b)(4) includes 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, 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 panel was detached from the side rail mechanism.The citadel plus bed was used with the patient when the event occurred and in that way contributed to the event.This complaint is deemed reportable due to the safety side detachment from the 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15864385
• MDR Text Key: 307799361
• Report Number: 3007420694-2022-00193
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200518
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• 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?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• 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
• Patient Sex: Female