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

Model Number FXX21A4A4AKFBB

Device Problem Crack (1135)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

An inspection of a citadel plus bed frame returned after 4 days rent revealed a side rail malfunction.Based on the photographic evidence provided, the side rail lower arm (part of the side rail mechanism) was cracked and the extension frame on which the side rail was installed was twisted.The customer did not inform how the damaged occurred.When the issue was detected, no patient was involved.No harm 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 crack of the side rail lower arm might be related to an excessive force applied to the side rail.This is in line with side rail condition.Based on photographic evidence provided, the side rail mechanism was mechanically damaged.The arjo representative who inspected the bed frame assessed that this kind of damaged may occur during hitting in a wall.According to citadel plus instruction for use (831.374): ¿ensure pathway is clear or cords, hoses and obstacles before driving bed forward or backwards.¿ 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.To conclude, the side rail was damaged and from that perspective the citadel plus bed did not meet the performance specification.The bed was not in use when the issue was detected.No injury was reported.The complaint was decided to be reportable due to the cracked side rail mechanism.

Event Description

An inspection of a citadel plus bed frame returned after 4 days rent revealed a side rail malfunction.Based on the photographic evidence provided, the side rail lower arm (part of the side rail mechanism) was cracked and the extension frame on which the side rail was installed was twisted.The customer did not inform how the damaged occurred.When the issue was detected, no patient was involved.No harm was claimed.

• 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: 15378003
• MDR Text Key: 305883735
• Report Number: 3007420694-2022-00147
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756679
• UDI-Public: (01)05055982756679(11)210812
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FXX21A4A4AKFBB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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