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 Problem Bone Fracture(s) (1870)

Event Date 05/15/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, it was reported by a customer representative that a patient fell from a citadel plus bed frame at time of bathing.The patient was rolled to the side to facilitate the bathing, the patient leaned against the side rail, which was locked in the raised position.After two or three minutes, the customer staff heard a "click" and simultaneously, the patient fell to the ground and the side rail dropped.The patient had pre-existing fracture to left tibia.The customer staff suspected that re-fracture occurred therefore the computed tomography (ct) scan was planned.On (b)(6) 2022, arjo became aware that ct scan showed fracture of the femur.It was not possible to apply a cast to stabilize splints.The patient had increased medications for pain management.

• 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
• MDR Report Key: 14652481
• MDR Text Key: 294874814
• Report Number: 1419652-2022-00027
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756471
• UDI-Public: (01)05055982756471(11)190509
• Combination Product (y/n): N
• Reporter Country Code: NS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX711A3B2ALVBA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2022
• Distributor Facility Aware Date: 05/16/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 227 KG