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

Model Number	CX611B3F4AMAB0
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.Further information will be available in the next report.
Event or Problem Description
It was claimed by customer that the mattress was not filling in the center and the patient's pressure sore worsened.The patient sustained a serious injury (left hip buttocks injury) the device was swapped out.During the evaluation was found that the airbox malfunctioned.The compressor leakage was identified.
Additional Manufacturer Narrative
The investigation is ongoing.Further information will be available in the next report.
Additional Manufacturer Narrative
It was claimed by the customer that the mattress was not filling in the center, and the existing patient's pressure sore at the left hip buttock worsened.The medical intervention was required.The ishikawa diagram (fishbone diagram) to identify and organize potential causes of the problem was used.Several factors that might have impacted the patient's injury worsening were identified based on the review of previous complaint and review of literatures, such as: (1) equipment (alleged mattress not filling in the center due to compressor leakage), (2) people (facility staff), (3) environment (such as frequency of repositioning), (4) patient (health, physical condition).(1) during the evaluation of the bed in the service center, the issue with the compressor leakage was recreated and the broken compressor submodule was replaced.The device was in use since 2019 and this component was not replaced before, therefore it can be concluded that the part deteriorated due to time in use.Despite the product failure, the low pressure alarms (visual and audible) were working correctly during inspection.The instruction for use for citadel patient care system (ifu, 830.238-us rev 13 ¿ 2024-06) stated that the device is equippped with the alarms (visible and audible) that informs users about the system deflation: "once an alarm condition is detected, the typical delay in sounding the audible and visual alarm signals is no more than one second.An amber-colored alarm indicator will light up when an alarm condition is present.Typically, the alarm indicator is accompanied by another indicator to indicate why an alarm occurred." the customer confimed that the malfunction was detected correctly by the alarm system when the system was used with the patient and informed them about the issue.(2) additionally the ifu inform users about the action that should be done when the system malfunction is being detected, what parts should be check and what actions should be done to resolved the issue.Ifu awares users to "contact arjo if you are unable to correct a symptom by performing the suggested action listed in the table below." the customer facility called arjo not immediately when the alarm indicated low pressure, but several days later when the patient's pressure sore worsened.(3) the ifu informs users about the way of: "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." according to the clinical consultant, the customer was aware of the patient's repositioning protocols and monitoring the skin condition.(4) the customer did not provide any additional information regarding the patient state of health.It was just claimed that the patient already had a wound it was just worsening.To conclude, the compressor leakage found did not lead to the worsening of the patient's sore by itself.The system malfunction was detected; however, alarms were working as intended to notify facility about the issue.Despite being alerted and aware, the staff decided to leave the patient on the system, which indicating about the issue.The citadel system was used with the patient; therefore it played a role in the event.The system did not meet the specification as the failure was observed.The complaint was assessed as reportable due to the allegation that the existing patient's pressure sore worsened while using the citadel patient care system.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Common Device Name: 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: 21397296
• Report Number: 3007420694-2025-00039
• Device Sequence Number: 7871812
• Product Code: IOQ
• UDI-Device Identifier: 05056097342184
• UDI-Public: (01)05056097342184(11)190918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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
• Operator of Device: Other
• Device Model Number: CX611B3F4AMAB0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/19/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown