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

Model Number FX811B3B4AMABB

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was claimed by the customer staff that the citadel plus bed frame was damaged.One of the side rail panels was detached from the side rail mechanism.The bed was in use.No injury was reported.

Manufacturer Narrative

It was claimed by the customer staff that the citadel plus bed frame was damaged.One of the side rail panels was detached from the side rail mechanism.The bed was in use.No injury was reported.The review of post-market surveillance data and the investigation carried out at the manufacturer site revealed that the main factor which could lead to the side rail mechanical damage might be related to an excessive force applied to the side rail.This is in line with side rail condition.It was mechanically damaged, based on photographic evidence provided the side rail panel was detached from the side rail mechanism (all screws holding the panel were ripped off).According to citadel plus instruction for use (831.374): the operation of the side rails should be checked daily by the device owner.If the malfunction is identified, arjo or approved service agent should be contacted.Based on the analysis of the complaints, the external excessive force must first compromise the integrity of the safety side prior to breaking it.The side rail was damaged and from that perspective the citadel plus bed did not meet the performance specification.The device was in use but no injury occurred.The complaint was decided to be reportable due to the side rail panel detachment.

• 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: 16032275
• MDR Text Key: 308167094
• Report Number: 3007420694-2022-00230
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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 Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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: Male