MAUDE Adverse Event Report: RESPIRONICS, INC. ELEGANCE WITH SSR 230V50HZ EU; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1099973

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation of elegance with ssr that the patient alleges that the device does not generate mist.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: ELEGANCE WITH SSR 230V50HZ EU
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18416971
• MDR Text Key: 331575929
• Report Number: 2518422-2023-38416
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001715
• UDI-Public: 00383730001715
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K102240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099973
• Device Catalogue Number: 1099973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1