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

Model Number CX811A3F3AMAB0

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Arjo was informed about the incident with the citadel bed frame involvement.It was reported that the patient fell out from bed and the exit detection alarm did not trigger.No injury was sustained.After the event, an arjo representative visited the customer to perform the device inspection.The service technician could not replicate the reported problem and did not find any bed malfunction.

Manufacturer Narrative

Investigation is ongoing.The follow-up will be provided within next report.

Manufacturer Narrative

Arjo was informed about the incident with the citadel bed frame involvement.It was reported that the patient fell out from the bed and the exit detection alarm did not trigger.After the event, an arjo representative visited the customer to perform the device inspection.According to the information provided, the technician tested the bed several times (with the side rails lowered and raised, the bed raised to its highest position and lowered to its lowest position) and found no damage or malfunctions.All the bed cables were also not damaged and did not have any open connections, the scale read the weight correctly and the exit detection alarm worked properly.The technician suspected that the exit detection alarm may not have been turned on.For better understanding of the circumstances of the incident, we have contacted the initial reporter who stated that at a time of the fall, the bed side rails were raised.The patient was lying on bed and decided to try to get out of bed for a walk.The patient had bilateral leg weakness and after leaving the bed, he immediately fell to the ground.The nurses heard that the patient hit the floor but did not hear the alarm.Another nurse picked up the pillow from the floor and threw it on the bed and then the bed alarm triggered and started to sound.Based on the information gathered, it is unknown which alarm had triggered since the device evaluation showed that the exit detection alarm was working properly.Based on the information gathered, we concluded that the cause of the patient fall was related to his medical condition and attend to leave the bed despite the side rails being raised.To sum up, the citadel bed frame was used for a patient treatment when the patient fell out of the device and from that perspective the equipment did not meet its performance specifications.This complaint was deemed reportable due to allegation of patient fall from the bed.No injury was sustained.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15173542
• MDR Text Key: 304308523
• Report Number: 3007420694-2022-00129
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)201109
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 07/10/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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