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  

Manufacturer Narrative

The investigation is ongoing.Further information will be available in the next expected report.

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.

Manufacturer Narrative

It was established that the patient was trying to reach for the call light, but fell from the bed through the opened safety side.The safety side was down due to hospital policy.No device failure was observed.No customer allegation regarding device functionality was claimed.The instructions for use for citadel bed frame (830.213-en rev.12) describes the potential risk of patient's fall/inadvertent exit on several occasions: - "to minimize the risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." - "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family." to sum up, the exact cause of the reported patient¿s fall is considered usage of the device.No device failure that could contribute to this event was found.The arjo device was used for patent treatment during the event occurred.No device failure was found during evaluation.This complaint is reportable due to allegation of patient's fall from the bed and sustained serious injury.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 19189635
• MDR Text Key: 341117457
• Report Number: 3007420694-2024-00114
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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 Model Number: CX711A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male