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  malfunction  

Event Description

Following the information provided the patient fell from the bed.The caregiver did not engage the bed alarm or have the nurse call light alarm cord connected.There was also concern with how soft the volume of the bed alarms are and that it may be hard to hear the alarms outside of the room.There is no indication of any injury sustained.

Manufacturer Narrative

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

Manufacturer Narrative

Despite multiple attempts it was not possible to obtain more details from the customer.The quality check performed after picking the bed up from the customer did not reveal any malfunctions, the device was fully functional.Even though it was confirmed that the bed exit alarm was not set up and the nurse call cable was not connected, none of these systems itself could have caused or contributed to the fall.The instructions for use for citadel patient care system (830.238-en rev.G) takes into consideration the risk of patient's fall/inadvertent 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 uproght 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.

Event Description

Following the information provided the patient fell from the bed.The caregiver did not engage the bed alarm or connect the nurse call light alarm cord.There is no indication of any injury sustained.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13257068
• MDR Text Key: 283829078
• Report Number: 3007420694-2022-00006
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)180313
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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): Other