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

Model Number CX811A3F3AMAB0

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow up report once the investigation is completed.

Event Description

Following the information provided the customer placed a service call for the citadel bed and requested it to be picked up.When the bed was brought back to the service center the arjo technician noticed that the side rail lower arm pin that holds the side rail in place, slided out, which resulted in side rail lower arm detachment.The damage occurred before patient placement, so no patient was involved.No injury was sustained.

Manufacturer Narrative

Arjo received a customer complaint regarding a citadel bed.Following the information provided the customer called arjo and requested for the citadel bed to be picked up due to damaged side rail.When the bed was brought back to the arjo service center the arjo technician noticed that the side rail lower arm pin that holds the side rail in place, slid out, which resulted in side rail lower arm partial detachment.There was no patient involvement.No injury was sustained.Based on the information received from an arjo service consultant the citadel bed was repaired.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 partial detachment might be related to an excessive force applied to the side rail.This is in line with the side rail condition, it was mechanically damaged (the side rail lower arm pin, that holds the side rail in place, slid out).Furthermore, the arjo service consultant indicated that the problem could have been caused by improper use of the bed - hitting the bed against an object, and the vibration could have caused the pin to slip out.The instructions for use for citadel bed (830.238-en) includes maintenance procedure and the following information: ¿inspect all parts of the citadel patient therapy system for damage prior to returning to use.Contact arjo for service or replacement.¿ based on the analysis of the complaints, the external excessive force must first compromise the integrity of the safety side prior to detachment.Arjo device failed to meet its performance specification since the side rail was partially detached from its mounting points due to the pin that had partially slipped out.The bed was not used for patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation of safety side partial detachment.

• Brand Name: CITADEL BED FRAME
• 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: 16033208
• MDR Text Key: 308167023
• Report Number: 3007420694-2022-00232
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• 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