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 Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the patient fell out of the bed, injuring herself and damaging the patient lower right side rail.To date no details about the sustained injuries was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The citadel bed is certified to meet the requirements of standard iec 60601-2-52, edition 1.1 2015-03, which describes the general requirements for the design of medical beds.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: - "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 failed to meet its performance specification since the side rail was damaged.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to patient's fall from the bed.

Event Description

Following the customer¿s allegation, the female patient weighing 350 lbs fell out of the bed.The customer stated that the patient sustained an injury and was hospitalized, however no details about the injury were provided.The caregiver who attended the patient at the time of the event was a traveling nurse and did not notify the supervisor about the fall when the incident occurred, therefore the available information are limited.The customer informed that the side rail allegedly gave out when the patient put her legs on it.The patient was agitated before the incident; after the fall a sitter was placed by the patient.The bed was taken out of use by the customer - it was moved to the basement, from where it was picked up by arjo representative.The bed right foot side rail was damaged as a result of the fall - it was bent outwards and the cover was partially detached.The device was repaired by replacements of the side rail.

• 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: 13385803
• MDR Text Key: 285180099
• Report Number: 3007420694-2022-00010
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)191113
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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
• Patient Sex: Female
• Patient Weight: 159 KG