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

Model Number FX711A3B2ALVBA

Device Problem Use of Device Problem (1670)

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

Event Date 01/21/2023

Event Type  malfunction  

Manufacturer Narrative

Arjo received a customer complaint with an allegation of a patient fall from a citadel plus bed frame that was in use with an auralis plus mattress.During the care procedures provided by the customer staff, the patient was turned on the left side.On that time, the side rail unlocked and lowered what resulted in the patient fall on the floor mat.No injury occurred.During the interview conducted following the event, the customer¿s representative made an assumption that the side rail may not have been pushed up and locked in place.The root cause identified by the customer is in line with the device evaluation results.During the inspection of the device, the side rails locked correctly and no malfunction was found.The citadel plus instruction for use (831.374) instructs user to: ¿prior to engaging any mattress turn feature, make sure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position.¿ ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ additionally, 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 device condition, it was concluded that the side rail may not have been locked in the upright position therefore it opened unexpectedly.The additional training was provided to the customer.Arjo device was used for the patient treatment when the event occurred and played a role in the event.The side rail opened and from that perspective the citadel plus bed did not meet the performance specification.The complaint was assessed as reportable due to allegation of the patient¿s fall, which may lead to serious health consequences.

Event Description

Arjo received a customer complaint with an allegation of a patient fall from a citadel plus bed frame that was in use with an auralis plus mattress.During the care procedures provided by the customer staff, the patient was turned on the left side.On that time, the side rail unlocked and lowered what resulted in the patient fall on the floor mat.No injury occurred.

• 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: 16320970
• MDR Text Key: 309506809
• Report Number: 3007420694-2023-00026
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX711A3B2ALVBA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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: Female