MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

Complaint: pt has been using the wrong compressor and nebulizer cup (philips respironics) with her medication and she also reported the medication is getting foamy in the compressor.Pt may also have been mixing other medications with the tobramycin in her compressor.Inhale 300 mg via nebulizer twice daily for 28 days on, followed by 28 days off, then repeat.

• Brand Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 12474812
• MDR Text Key: 271683722
• Report Number: MW5103921
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1