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

Model Number CXX22C4M1AABC0

Device Problems Unintended Movement (3026); Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

It was reported that the safety side was defective, the left foot side.When safety side was lowered, it activated the cpr function without any command given.

Manufacturer Narrative

Product inspection revealed that the cables of the safety side panel were defective.The safety side panel was replaced and thrown away.The simulation at the manufacturing site showed that when cables inside the safety side panel are defective, the movement of the safety side panel could trigger the electric cpr, leading to citadel mattress deflation.In normal circumstances, when cpr located on the safety side panel is used, the bed platform flattens and lowers, and mattress deflates to allow resuscitation.Therefore, initially, it was thought that the failure of the cables inside the safety side panel could cause the unintended movement of the bed platform.However, deeper analysis revealed that this type of failure does not activate the bed platform on its own.When the failure of cables occurs, the system interprets it as if the movement was initiated, but not activated.This means that the bed platform will not move until the button is physically pressed.There will be a mattress deflation because the cpr from the mattress is a separate function, and a movement of the safety side panel will activate the cpr dump valves of the mattress.This failure has not caused or contributed to a serious injury or death in the past, and it is considered unlikely it will lead to a serious injury or death in the future.Therefore, this type of failure will not be considered reportable in the future.The device failed its specification since the internal cables in the safety side panel were defective, there was no injury and no indication of patient involvement, the bed was not involved in the adverse event.

Event Description

Correction.The initial information have been wrongly interpreted.The safety side panel was lowered which caused the activation of electrical cpr from the mattress.There was no injury, no patient involvement.

• 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: 18099706
• MDR Text Key: 328655659
• Report Number: 3007420694-2023-00267
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 05055982795722
• UDI-Public: (01)05055982795722(11)201021
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 12/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CXX22C4M1AABC0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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