MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FX811B3B4AMABB

Device Problem Power Problem (3010)

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

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Arjo became aware of the event involving citadel plus bed frame.The bed¿s power cable was placed under the bed and pulled out or cut.It caused that the bed¿s platform was not able to move out of the trendelenburg position.The problem occurred when the bed was in use by the patient.The patient was moved to another bed and no injury was sustained.The bed frame was swapped out and repaired by the damaged cable replacement.

Event Description

Arjo became aware of the event involving citadel plus bed frame.The nurse reported that the bed wasn't able to move out of the trendelenburg position.The problem occurred when the bed was in use by the patient who was moved to another bed.No injury was sustained.The bed frame was swapped out and repaired by the damaged cable replacement.

Manufacturer Narrative

The bed inspection revealed that the openbus 1900 cable was torn.Arjo was not informed about the circumstances in which the cable was damaged.The damaged cable is a part of openbuss system.It¿s malfunction causes no electrical functions of the bed.Thus, the bed was stuck in the trendelenburg position.The main factor that could lead to the openbus 1900 cable being torn might be related to an excessive force applied to the cable due to the collision with obstacles.However, there was no customer allegation about the event causing bed damage.Thus, the exact root cause of the observed malfunction is impossible to define.According to the citadel plus instruction for use (ifu 831.374-en rev.I) to avoid device damage: - before driving bed forward or backwards using power drive system ¿ensure pathway is clear of cords, hoses and obstacles¿ - ¿keep all equipment, tubes and lines, loose clothing, hair and parts of the body away from moving parts and pinch points¿ the preventive maintenance section of ifu indicates to ¿carry out a full test of all electrical bed positioning functions (backrest, height, tilt, etc.)¿ weekly.The arjo device was not meeting its specification as the bed¿s openbus 1900 cable was damaged.The citadel plus bed was used for the patient treatment at time of the event.The complaint was decided to be reportable due to the allegation of the bed being stuck in trendelenburg position.No injury occurred.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 19002271
• MDR Text Key: 338880310
• Report Number: 3007420694-2024-00087
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)220311
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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