MAUDE Adverse Event Report: ARJOHUNTLEIGH AB CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FX811B3B4AMABB

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 03/07/2021

Event Type  malfunction  

Event Description

A morbidly obese ((b)(6)) was transferring from a citadel plus bariatric bed to commode chair by the bed size.When patient was about half way between, patient felt stuck on side rail of bed unable to lift up off of this rail, and the rail then broke which was supporting some of the body weight and patient descended to the floor slowly.This is the second time we have had this type of incident with citadel plus bariatric bed with its rail breaking off in the same manner.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH AB; 12625 wetmore road suite 308; san antonio TX 78247
• MDR Report Key: 11526512
• MDR Text Key: 241024939
• Report Number: 11526512
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FX811B3B4AMABB
• Device Catalogue Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Device Age: 2 YR
• Date Report to Manufacturer: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 182