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

Model Number FX811B3B4AMABB

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

An arjo representative observed at the time of a pick-up citadel plus bed frame that a hi-low actuator was detached from one side.The interviewed nurse informed only that this malfunction occurred at the time of use the bed frame by a patient.No injury occurred.The hi-low actuator is the component of the bed responsible for the high and low movement of the entire bed.The detachment of the actuator results in the bed movement to the reverse trendelenburg position.Based on the photographic evidence provided, the hi-low actuator was mechanically damaged, the plastic component which holds the actuator broke and the actuator detached from one side.The actuator can be mechanically damaged if the bed¿s movement is interrupted by the obstacle, for example when the obstacle is placed under the bed.However, due to unknown circumstances in which the malfunction occurred, this hypothesis and exact cause of the claimed malfunction could not be determined.The actuator was found to be mechanically damaged and from that perspective, the device did not meet performance specifications.The device was in use.It was decided to report this case as the detected malfunction of the hi-low actuator results in the unexpected movement of the bed platform.No injury was claimed.

Event Description

An arjo representative observed at the time of a pick-up citadel plus bed frame that a hi-low actuator was detached from one side.The interviewed nurse informed only that this malfunction occurred at the time of use the bed frame by a patient.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: 15770587
• MDR Text Key: 303636739
• Report Number: 3007420694-2022-00183
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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: Female