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

Model Number FXX21A4A1AKFBB

Device Problems Unintended Movement (3026); No Apparent Adverse Event (3189)

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

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A citadel plus bed frame raised without any command given.After 2 to 5 minutes, the e300 code was displayed on the side rail control panel.There was no indication that the bed was in use.No injury was claimed.

Event Description

It was initially claimed by the customer staff that a citadel plus bed frame raised without any command given.After 2 to 5 minutes, the e300 code was displayed on the side rail control panel.There was no indication that the bed was in use.No injury was claimed.The customer facility was visited by the arjo representative and the bed was tested.The claimed issue was not duplicated.After discussing with the customer staff, it was clarified that no unintended movement occurred, the bed lowering function allegedly did not work.The statement initially provided by the customer was inaccurate.

Manufacturer Narrative

It was initially claimed by the customer staff that a citadel plus bed frame raised without any command given.After 2 to 5 minutes, the e300 code was displayed on the side rail control panel.There was no indication that the bed was in use.No injury was claimed.The customer facility was visited by the arjo representative and the bed was tested.The claimed issue was not duplicated.After discussing with the customer staff, it was clarified that no unintended movement occurred, the bed lowering function allegedly did not work.The statement initially provided by the customer was inaccurate.Technician replaced the side panel on which is located the control panel which satisfied the customer.In summary, the complaint was initially assessed as reportable due to information indicating that the bed moved without any command given, in the course of the investigation, proved to be erroneous.No unintended movement occurred.Taking all the facts into account, this complaint is deemed not reportable to competent authority.Arjo will not be reporting future complaints of this type.However, arjo will continue monitoring the complaints and report any events in which death and/or serious injury occurred that arjo device contributed to.

• 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: 15797110
• MDR Text Key: 307800650
• Report Number: 3007420694-2022-00186
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756679
• UDI-Public: (01)05055982756679(11)210517
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/25/2022

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: FXX21A4A1AKFBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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