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

Model Number FXX21A4A1AABBA

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

Root cause has not been established yet.Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

The customer contacted arjo and informed about the malfunction citadel plus bed frame.The device evaluation revealed that the side rail panel was partially detached from the bed frame.The weld between the frame and the side rail mechanism was cracked.No patient was involved.No injury was claimed.

Manufacturer Narrative

The investigation is ongoing.The damaged part to be returned to the manufacturer for evaluation to establish root cause.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

The extension frame with broken weld was returned to the manufacturer on 03 oct 2023 and it is waiting for inspection.The evaluation results to be provided in the follow-up report.

Manufacturer Narrative

The damaged component was returned to arjo and forwarded to the supplier of this part to consult the root cause.The received from the supplier feedback allowed to exclude the supplier error as a potential root cause.The weld was not identified as cracked, the material was torn out.According to the supplier's opinion, a really big force had to be used to damage the part.Arjo device failed to meet its performance specification since the side rail was partially detached from the bed.The device was not in use when the issue was detected.The complaint was decided to be reportable due to the side rail partial detachment.No injury was claimed.

Event Description

The customer contacted arjo and informed about the citadel plus bed frame malfunction.The device evaluation revealed that the left side rail panel was partially detached from the bed frame.No patient was involved.No injury was claimed.The side rail partial detachment was caused by damage of the extension frame to which it was assembled.The extension frame weld was cracked.

Manufacturer Narrative

The visual inspection of the returned part conducted by the quality engineer on 13 oct 2023 confirmed that the weld was cracked.The communication with the supplier was initiated to establish the root cause.Additional information will be provided upon conclusion of the investigation.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17486683
• MDR Text Key: 320707152
• Report Number: 3007420694-2023-00184
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756617
• UDI-Public: (01)05055982756617(11)170706
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FXX21A4A1AABBA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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