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

Model Number CX811A3F3AMAB0

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

Following the information provided there was an allegation of a patient fall from the citadel bed.No injury was reported.

Manufacturer Narrative

The arjo representative was informed about the event involving citadel bed.Following information provided by the customer the caregiver had passed by the room and noticed that a patient was on the side of the bed eating.Subsequently, the caregiver left the room to attend to another patient.While the cargiver was taking care of the second patient heard a loud bang against the wall.She went immediately to check what happened and found the patient on the floor.It was confirmed that the patient did not sustain any injury.The arjo representative visited facility after the event.During interview the nurse alleged that nurse control panel was frozen and not working.The facility also alleged that the bed was slightly high and they were able to adjust the sensitivity of the bed exit alarm.This evaluation encompassed a scrutiny of its electrical components, communication cables, s-side operation (both electrical and mechanical aspects), caster functionalities, alarm systems.All functions worked as intended and no malfunction was found.The exit alarm detects patient¿s movements, however it will not restrain patient from leaving the bed.The root cause could not be confirmed as no device malfunction was found.The event was unwitnessed (the patient was found on the floor) therefore it is unknown why the patient fell from the bed frame.The device was used for patient treatment when the event occurred.No malfunction was found on the device.This complaint is deemed reportable due to the alleged 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
• 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: 17569727
• MDR Text Key: 321596834
• Report Number: 3007420694-2023-00191
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)170828
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CX811A3F3AMAB0
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2023
• Date Device Manufactured: 08/28/2017
• 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