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

Model Number CX811A3F3AMAB0

Device Problems Use of Incorrect Control/Treatment Settings (1126); Positioning Problem (3009)

Patient Problems Ulcer (2274); Unspecified Tissue Injury (4559)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

Following the information provided the patient was laying on the deflated mattress.It was reported that the patient had a stage 4 pressure injury on his sacrum.

Manufacturer Narrative

Additional information will be available upon investigation conclusion.

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Manufacturer Narrative

Following the information provided the patient with preexisting stage 4 pressure injury on the sacrum was laying on the deflated mattress.The customer reported that the preexisting pressure injury has gotten worse overnight.The device was evaluated after the event.No device malfunction was found.During the interview with customer, it was confirmed that the caregivers did not know how to use the bed controls function which caused the mattress deflation.The instruction for use (fu) for citadel patient therapy system provides a explanation on how to operate the device, including a step-by-step guide on attaching the air mattress.Additionally, there is a dedicated section within the ifu that provides an explanation of the functions of each mattress control panel button.Additionally, the document provides troubleshooting information to assist caregivers in resolving the problem related to mattress deflation.Pressure injuries are complex and are a result of many factors including: advanced age, immobility, co-morbidities, microclimate, incontinence and lack of being turned or repositioned frequently enough.The ifu for citadel bed (830.238-en) includes the following information related to the subject of the investigation: - "monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients.Give extra attention to skin over any raised side bolster and to any other possible pressure points and locations where moisture or incontinence may occur or collect.Early intervention may be essential to preventing skin breakdown." the device was used for a patient treatment when worsening of preexisting injury was noted by the caregivers, and from that perspective it played a role in the event.There was no device malfunction found which might led to reported mattress deflation.The complaint was reported in abundance of caution due to fact that the patient had preexisting stage iv pressure injury which has been worsened.

• 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
• 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: 16768206
• MDR Text Key: 313567969
• Report Number: 3007420694-2023-00082
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)220511
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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 Sex: Male
• Patient Weight: 159 KG