MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL BED FRAME; WASHER OF BODY WASTE RECEPTACLES

Model Number CX811A3F3AMAB0

Device Problem Insufficient Information (3190)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

Following the information provided, the patient fell out of the arjo citadel bed frame.No injury was reported.According to the customer's allegation, the staff didn't set the exit alarm correctly.The bed was evaluated by arjo representative.The inspection did not reveal any device malfunction.

Manufacturer Narrative

Following the information provided, the patient fell out of the arjo citadel bed frame.No injury was reported.According to the customer's allegation, the staff didn't set the exit alarm correctly.It was also confirmed that the side rail was in the lowered position when the event occurred.The bed was evaluated by an arjo representative.The inspection did not reveal any device malfunction which might led to patient fall.The instructions for use (ifu) for citadel bed frame system (830.213-en) includes the following information related to the investigated event: - "the patient movement detection system can be set to alarm when undesired movement of the patient occurs.The sensitivity of the patient movement detection, relative to the center of the deck, can be varied incrementally.The controls for the patient movement detection system are located on the foot end split side rails." - "the patient movement detection function should be checked periodically for correct operation and before each new patient uses the bed." - "the clinically-qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails." - "side rails / patient restraints - 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." the customer did not provided detail information regarding patient fall circumstances.Therefore, the cause of the patient fall could not be confirmed.The device was used for patient treatment when the event occurred.No malfunction was found on the device and it was working as intended.This complaint is deemed reportable due to the alleged patient's fall from the bed.

• Brand Name: CITADEL BED FRAME
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• 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: 17264443
• MDR Text Key: 318443965
• Report Number: 3007420694-2023-00162
• Device Sequence Number: 1
• Product Code: FLH
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)200626
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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