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

Model Number CX711A3F3AMAB0

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/02/2024

Event Type  Injury  

Event Description

Following the information gathered the patient fell out of bed.The customer also claimed that possibly the mattress was overinflated, but arjo technician found no device malfunction.It was established that the patient was trying to reach for the call light, but fell from the opened safety side part of a bed.Te safety side was down due to hospital policy.The patient received a neck injury due to the fall.It was confirmed to be a cervical fracture.The patient was transferred to a different hospital afterward.

• Brand Name: CITADEL BED FRAME
• 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: 19189634
• MDR Text Key: 341120725
• Report Number: 1419652-2024-00036
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441217015
• UDI-Public: (01)05059441217015(11)220204
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CX711A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2024
• Distributor Facility Aware Date: 04/03/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male