MAUDE Adverse Event Report: UNKNOWN NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The caller stated that she had nebulizers with defects.The caller stated that nebulizers had motors that are locked.The caller stated that there was no injury or property damage.Invacare (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17516376
• MDR Text Key: 321243046
• Report Number: MW5123325
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1