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

Model Number FXX21A4A1AABBA

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

Arjo received a copy of the customer report (b)(4) with allegation about a citadel plus malfunction which occurred at time of use the bed frame by a patient.The customer staff tried to raise the bed backrest section but it was impossible.The patient sustained the temporary respiratory distress in this event.Cpap (continuous positive airway pressure) was used to temporarily help with the respiration distress.The customer noted in the report that the 'security mode' was activated itself when the patient was installed on the bed, change of mode to 'manual mode' was impossible.When the bed frame was tested without the patient, it worked correctly.

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

Arjo received a copy of the customer report (ref.R2211813) with allegation about a citadel plus malfunction which occurred at time of use the bed frame by a patient.The customer staff tried to raise the bed backrest section but it was impossible.The patient sustained the temporary respiratory distress in this event.Cpap (continuous positive airway pressure) was used to temporarily help with the respiration distress.The customer noted in the report that the 'security mode' activated itself when the patient was installed on the bed, and change of mode to 'manual mode' was impossible.The customer added that when the bed was tested without the patient, it worked correctly.The arjo citadel plus bed frames are equipped in the lockout function which can be used to prevent operation of the controls.To lock (prevent) or unlock (allows) functions, the lockout button located on the bed side rail control panel needs to be pressed.The led indicator above the lockout button informs if the function is activated (led on) or deactivated (led off).The activated lockout function (led on) automatically disable the bed¿s electrical functions (including lifting the backrest) until the function is unlocked.The customer called the activated lockout function as 'security mode¿ and deactivated lockout function as ¿manual mode¿.The lockout function allegedly activated itself and could not be unlocked.This allegation was not confirmed.The arjo technician visited the facility but the bed could not have been localized to be inspected.He contacted several caregivers and employees but no one was aware of this failure and no additional information was revealed.The technician received information that the initial reporter is not working in this facility anymore so no more details related to the circumstances in which the alleged failure occurred are available.The device involved in the event was a customer property.The customer has never asked arjo for a technical inspection or repair of this bed.We have not found any service records related to the bed in question.The arjo bed frame played a role during this event as it was used by the patient.The bed allegedly failed its performance specification since the lockout function failed (activated itself and could not be unlocked) so raising of the backrest section was impossible.As per customer report, the failure was not confirmed because when the bed was tested without the patient, it worked correctly.The patient sustained the temporary respiratory distress in this event therefore we decided to report this incident in abundance of caution.

• 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: 14345188
• MDR Text Key: 294657876
• Report Number: 3007420694-2022-00061
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097320427
• UDI-Public: (01)05056097320427(11)211104
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FXX21A4A1AABBA
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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 Weight: 159 KG