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

Model Number FX811B3B4AMABB

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Decreased Respiratory Rate (2485)

Event Date 09/04/2021

Event Type  Injury  

Event Description

Arjo was received a copy of medwatch report (uf report # (b)(4)) in which was indicated that a patient fell from an citadel plus bed and was found on the floor with detached endotracheal tube.After the fall, the patient was connected to a bag valve mask and manually administered breaths.The patient was lifted to a gurney and transported for stats computed tomography.No fractures were noted.It was noted by the customer that the patient was deeply sedated and paralyzed so it is unknown why the patient fell from the bed.

• 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: 12670887
• MDR Text Key: 280572311
• Report Number: 1419652-2021-00038
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)200527
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/21/2021

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: No Information
• Device Model Number: FX811B3B4AMABB
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2021
• Distributor Facility Aware Date: 10/14/2021
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 120