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

Model Number FX811B3B4AMABB

Device Problem Activation Problem (4042)

Patient Problem Respiratory Failure (2484)

Event Date 01/19/2024

Event Type  Death  

Event Description

It was claimed that the patient went into respiratory distress at the time of use of the citadel plus bed frame.The facility staff tried to lower the backrest section of the bed to provide resuscitation but the electrical cardiopulmonary resuscitation function (cpr) did not work.Allegedly, the error code was displayed on the side rail control panel at that time.The patient¿s condition deteriorated.The patient passed away two days after this event.The customer¿s allegation about the malfunction of electric cpr and occurring of the error code on the side rail control panel was not confirmed during the bed frame comprehensive evaluation conducted by the arjo representatives.The bed passed all tests, all cprs worked, no error codes were displayed on the side rail.

• Brand Name: CITADEL PLUS
• 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
• MDR Report Key: 18675285
• MDR Text Key: 335005816
• Report Number: 1419652-2024-00022
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2024
• Distributor Facility Aware Date: 01/19/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 250 KG