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

Model Number FXX21A4A4AKFBB

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/12/2022

Event Type  malfunction  

Manufacturer Narrative

Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

It was claimed by the customer staff that the side rail was broken.The device evaluation revealed that the side rail panel was detached.The bed was damaged when a patient was getting up from the bed frame.No injury was claimed.

Manufacturer Narrative

It was claimed by the customer staff that the side rail was broken.The device evaluation revealed that the side rail panel was detached.The bed was damaged when a patient was getting up from the bed frame.No injury was claimed.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 detachment might be related to an excessive force applied to the side rail.This is in line with the event description, the side rail was damaged by the patient who shifted all of their weight on the side rail during getting up.The photographic evidence revealed that the side rail panel was mechanically damaged, it was detached from the side rail mechanism (the screws holding the panel were ripped off).The instruction for use for citadel plus bed frame (ifu document number: 831.374_en) includes preventive maintenance procedures for side rails: 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.Ifu includes also safety information: ¿caregiver should always aid patient in exiting the bed.¿ based on the analysis of the complaints, the external excessive force must first compromise the integrity of the safety side prior to breaking it.Arjo device failed to meet its performance specification since the side rail panel was detached from the side rail mechanism.The citadel plus bed was used with the patient when the event occurred and in that way contributed to the event.This complaint is deemed reportable due to the safety side detachment from the bed frame.

• 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: 15968014
• MDR Text Key: 308165388
• Report Number: 3007420694-2022-00206
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756679
• UDI-Public: (01)05055982756679(11)210608
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FXX21A4A4AKFBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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 Sex: Male