MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ESSENCE; NEBULIZER

Model Number 1099966

Device Problem Failure to Deliver (2338)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Serial number provided in complaint was not found when performed database search.(b)(6).Device returned to the manufacturer per tracking, but not yet checked into database.

Event Description

The manufacturer was contacted in reference to an innospire essence device.The reporter stated the liquid (medication) in the device would not convert to mist.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: INNOSPIRE ESSENCE
• Type of Device: NEBULIZER
• 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: 18620049
• MDR Text Key: 334375355
• Report Number: 2518422-2024-05371
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170853
• 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: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099966
• Device Catalogue Number: 1099966
• Device Lot Number: 181220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1