MAUDE Adverse Event Report: ARJO INC. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FX811B3B4AMABB

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2023

Event Type  malfunction  

Event Description

The bed tilted too far to the left ¿ "left turn assist" mode was set on the bed.Here's a note from the biomed tech that tested the bed: i went up and did a function test on the bed.The bed worked fine.The only physical thing wrong with the bed that i had seen was the 4 safety lights on the bottom and the plastic piece under the bed was broken off as well.The break light one was still red even though the break was turned on.I tested the turn assist on the bed and noticed that the left side of it gets really high especially at 36¿ width even when i tested the bed on the 48¿ width it was still kind of high.I also noticed that the turn assist can be activated even if the side rails are down, on the citadel plus.I also noticed that you have to turn the turn assist off, it¿s not a timed therapy.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJO INC.; 2349 w. lake st.; suite 250; addison IL 60101
• MDR Report Key: 16973549
• MDR Text Key: 315678819
• Report Number: 16973549
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2023

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 Model Number: FX811B3B4AMABB
• Device Catalogue Number: 47129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26280 DA
• Patient Sex: Female