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); Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

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 verity 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.

Manufacturer Narrative

The investigation is pending.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

The investigation confirms that the skin iq top cover material was thoroughly tested for biocompatibility, skin irritation effects and skin sensitisation to ensure that it has no negative effect on patient¿s skin.The tests confirmed that the coverlet meets the requirements for safety within the intended use, therefore it is concluded that the skin iq did not contribute to the injury and is not considered related.The citadel patient care system pump is equipped with visual indicators of the therapy mode that is currently activated.The alternating pressure has a separate indicator diode that when lit, means that the alternating therapy mode is activated.The indicators are placed on the front pump control panel.The ifu includes instructions of how to activate each of the therapy modes.The citadel bed was evaluated by an arjo representative, who did not find any fault.The bed was working in accordance to the specification.In the course of investigation it was determined that: - alternating pressure mode was not turned on, which influenced on the pressure applied to the patient's body - the mattress cells were not inflated interchangeably, which would reduce the pressure on the same body parts, helping to maintain good skin condition.Instead, the mattress was inflated evenly on the whole surface.- the ifu informs also that the pulsation/alternating pressure (ap) therapy is an optional configuration, not the default setting.The ifu for citadel patient therapy system (b)(6) includes the following information regarding the therapy settings and skin care: - "individual patient needs should be assessed and the pressure settings should be adjusted to meet each patient's individual needs".- "skin care ¿ 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".Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was performing as intended.No malfunction was found during the device evaluation.This complaint is deemed reportable due to allegation of serious injury sustained (development of deep tissue injury) during use of arjo equipment.

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 patient care system used with skin iq coverlet as a system.Upon admission of the patient to the transitional care unit (tcu) on (b)(6) 2021, the hospital certified wound care nurse did not find any visual or palpable signs of pressure injury.The customer stated that first signs of the dti were observed on (b)(6) 2021 - red dark skin over coccyx area.According to the hospital's manager the dti developed, inter alia, because the citadel alternating pressure setting was not automatically activated 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
• 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: 13010545
• MDR Text Key: 282629383
• Report Number: 3007420694-2021-00168
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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