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

Model Number CX811A3F3AMAB0

Device Problem Positioning Problem (3009)

Patient Problem Ulcer (2274)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the patient developed a bedsore while using the citadel bed.The customer complained that the bed was stuck and not able to be operated, because an error code e410 appeared.The error code could not be reset.As a result the patient was left in an uncomfortable position, developing a bedsore.The stage of the pressure injury is currently unknown.The patient was taken out of bed when the issue was noticed and the bed was isolated to prevent using it.

Manufacturer Narrative

Based on the available information the root cause of complained scenario cannot be determined.The error sub-code indicates that the side rail position sensor, that is mounted on the wire assembled into the side rail, was faulty.The error code caused that the bed positioning functions were inoperable.Since the bed was repaired by replacement of the whole side rail assembly.Patients therapy should always be combined with an individualized monitoring, repositioning and wound care program.It is worth to highlight that arjo therapeutic systems represent only one aspect of a pressure ulcer management protocol - all other aspects of care (patient¿s condition, implemented procedure of monitoring, skin care, regular and frequent re-positioning routine) should be considered by the prescribing clinician.Early intervention with repositioning at regular intervals, adding protective layers between the skin and the medical device where possible, securing devices with appropriate tapes to prevent friction and careful monitoring of moisture associated with the device may decrease the incidence or severity of injuries in the hospitalized patient.The ifu for citadel bed (830.213-en rev.E) 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." "carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.)" and "check that the patient controls, caregiver controls and attendant control panels operate correctly" - these are the preventive maintenance activities that should be performed by the caregiver weekly, and that allow to detect any possible malfunctions prior to use.Arjo device failed to meet its performance specification since an error code occurred disabling the bed movement.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable in abundance of caution due to allegation of pressure injury sustained during use of arjo device.

Event Description

Following the information provided the patient developed a bedsore while using the citadel bed.The customer complained that the bed was stuck and not able to be operated, because an error code e410 appeared.The error code could not be reset.Allegedly as a result the patient was left in an uncomfortable position, developing a bedsore.The stage of the pressure injury is unknown.The patient was taken out of bed when the issue was noticed and the bed was taken out of use.The evaluation of the bed revealed that the error codes e410 - subcode e405 occurred on the bed, meaning that the position of the right foot side rail controller was not detected by the electrical system.In such case the control panel wiring needs to be checked.The bed was repaired by replacement of a whole side rail after being returned to service center.

• 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: 13994239
• MDR Text Key: 289866220
• Report Number: 3007420694-2022-00045
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05055982755764
• UDI-Public: (01)05055982755764(11)180205
• 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
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/05/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/05/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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