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

Model Number CXX21A6R4AMFA0

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was claimed by the customer that the patient fell while was trying to get out of bed.The side rail panel detached when the patient sat on it.The screws holding the panel to the metal plate were ripped off.No injury was claimed.The patient suffered from dementia.

Manufacturer Narrative

Following information gathered during interview with the customer representative, the bedridden, disoriented patient with dementia wanted to leave the bed.The patient put his legs through the raised side rail panel, supported himself against the panel and sat down on it.This caused the side rail to detach and patient fell to the floor.The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor that 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 side rail condition, it was mechanically damaged (the screws holding the side rail panel were ripped) and circumstances in which the event occurred (the side rail was loaded by the patient who sat on it).The instructions for use for citadel bed (ifu document number: 830.238_en) state in the safety information section: - "the caregiver should always aid patient in exiting the bed." - "to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." - "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind." arjo device failed to meet its performance specification since the side rail detached.The complaint decided to be reportable due to the patient's fall as a consequence of the side rail detachment.

• 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: 18797335
• MDR Text Key: 336512778
• Report Number: 3007420694-2024-00058
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2024

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: Lay User/Patient
• Device Model Number: CXX21A6R4AMFA0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 150 KG