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

Model Number CX811A3F3AMAB0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Following the information provided the patient fell from the citadel bed.The bed exit alarm did go off.There is no indication of any injury as a result of the event.

Manufacturer Narrative

The quality check performed after the bed was returned to the service center confirmed that the bed was in full working condition.No malfunction was identified.Based on the collected information the root cause of the investigated event cannot be established.No details regarding circumstances of the fall were possible to be obtained from the customer.The instructions for use for citadel patient care system (830.238-en rev.G) takes into consideration the risk of patient's fall/inadvertent bed exit on several occasions: "specialty surfaces have different shear and support characteristics than conventional surfaces and may increase the risk of patient (.) inadvertent bed exit.Monitor patients frequently to guard against patient entrapment." "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.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed (.).It is recommended that side rails (if used) be locked in the full upright position when the patient is unattended." arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was performing as intended.No malfunction was found during the device evaluation.This complaint is deemed reportable due to allegation of patient's fall from the bed.

• 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: 12539014
• MDR Text Key: 273554601
• Report Number: 3007420694-2021-00126
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)180321
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other