MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PATIENT CARE SYSTEM; BED, FLOTATION THERAPY, POWERED

Model Number CX811A3F3AMAB0

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 11/02/2021

Event Type  Injury  

Event Description

According to the information provided by the customer the patient sustained deep tissue injury (stage 4 coccyx wound) while being placed on arjo citadel bed.The customer stated that first signs of the dti were observed on (b)(6) 2021.According to the hospital's manager the dti developed for a variety of reasons, including the fact that the skin iq coverlet was unplugged from the power supply and the citadel alternating pressure setting did not activate automatically as a default mattress setting.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 13010544
• MDR Text Key: 282275423
• Report Number: 1419652-2021-00048
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)190219
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2021
• Distributor Facility Aware Date: 11/16/2021
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male