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

Model Number CXX2C6Q4AMBA0

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The review of post-market surveillance data and the investigation carried out 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 described by the arjo service technician and photo evidence attached to the complaint record, the side rail was mechanically damaged (all screws holding the panel were ripped off).Additionally, it was indicated that the patient was leaning with legs against the side panel.The instructions for use for citadel bed frame system (830.213-en) includes the general instructions regarding use, correct operation of the side rails and other relevant warnings.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 was detached.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of side rail detachment and the patient fall which resulted in minor injury.

Event Description

Arjo received a customer complaint regarding a citadel bed frame.Following the information provided a patient was leaning with legs against the side panel, which broke off.The patient fell out of bed and onto the side panel.The slight hematoma in the head area (face) was sustained by the patient as a consequence.

• Brand Name: CITADEL BED FRAME
• 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: 16633218
• MDR Text Key: 312217850
• Report Number: 3007420694-2023-00063
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756402
• UDI-Public: (01)05055982756402(11)161129
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CXX2C6Q4AMBA0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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: 150 KG