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

Model Number CX811A3F3AMAB0

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Pain (1994); Swelling/ Edema (4577)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

The process of gathering information is ongoing.The results of the analysis will be provided to the follow-up report.

Event Description

It was reported by the facility nurse manager that the patient fell from the citadel bed.The patient leaned against the side rail that broke off causing the patient fall.As a consequence sustained the soreness and edema in the left arm treated with first aid measures.The event was unwitnessed.The nurse noticed the patient on the floor when went to the patient's room.

Event Description

It was reported by the facility nurse manager that the patient fell from the citadel bed.The patient leaned against the side rail that broke off causing the patient fall.As a consequence, the patient sustained the soreness and edema in the left arm treated with first aid measures.The event was unwitnessed.The nurse noticed the patient on the floor when went to the patient's room during a routine check.The exit alarm was turned off on this bed.

Manufacturer Narrative

The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor which could lead to the side rail damage might be related to an excessive force applied to the side rail.This is in line with the side rail condition, it was mechanically damaged (the side rail panel detached) and circumstances in which the event occurred (the side rail was loaded by the patient who leaned against the side rail).Following the instructions for use dedicated to citadel bed frame system (830.213-en rev.12): "caregivers should assess risks and benefits of side rail/ restrain use in conjunction with individual patient needs" "to minimize risk of falls or injury, he bed should always be in the lowest practical position when the patient is unattended." to sum up, arjo device failed to meet its performance specification since the side rail detached.The device was used for a patient treatment when the failure occurred.The complaint decided to be reportable due to allegation concerning patient fall.The patient sustained non 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18214106
• MDR Text Key: 329080940
• Report Number: 3007420694-2023-00284
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)201012
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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 Age: 36 YR
• Patient Sex: Male