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); Skin Tears (2516)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's allegation about the side rail malfunction was not confirmed.During the device inspection conducted by the service team lead directly following the event, no issue with the side rail locking mechanism was found (it operated correctly).Based on the results of the bed frame evaluation it may be assumed that the most likely scenario is that the side rail was incorrectly locked in the upright position therefore it opened and the patient fell.The instruction for use for citadel plus bed frame (ifu, 831.374_en) includes below information: ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ "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.¿ additionally, according to the ifu, 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.The bed frame was in use when the left side rail unexpectedly opened therefore the arjo device played a role in the event.During the bed frame evaluation, no bed malfunction was found, the device was meeting its specification.The complaint was assessed as reportable due to the indication about the side rail disengaging during use resulting in the patient's fall.

Event Description

It was claimed by the customer staff that a patient fell from a citadel plus bed frame used with a maxi air ets mattress with the activated turn feature.Allegedly, the left side rail could not be secured correctly at that time.The skin tear on the patient¿s nose was reported as the outcome.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18289607
• MDR Text Key: 330832025
• Report Number: 3007420694-2023-00295
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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: 136 KG