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

Model Number FXX21A4A4AKFBB

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Pain (1994); Subluxation (4525)

Event Date 12/14/2023

Event Type  Injury  

Event Description

It was claimed that when the staff member was rolling a patient on a bed, a side rail collapsed.As a result, the patient fell from the citadel plus bed frame.It caused the injury to the patient and the nurse.The staff arm was caught under the patient causing soft tissue injury of the nurse¿s shoulder.The patient fell on the knees which resulted in kip, knee and ankle pain, and the dislocation of the patient¿s knee.The bed¿s inspection conducted following the event by the arjo technician revealed that the incorrect air mattress (non-arjo) was being used on the bed.It was too wide causing difficulties in the side rail locking.

• 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: 18433941
• MDR Text Key: 331779270
• Report Number: 1419652-2024-00001
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756679
• UDI-Public: (01)05055982756679(11)171005
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FXX21A4A4AKFBB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2024
• Distributor Facility Aware Date: 12/14/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 255 KG