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

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2019

Event Type  No Answer Provided  

Event Description

Treating an asthma attack with a nebulizer that had insufficient instructions.Unable to use.Luckily an inhaler was available.Critical part was not identified in photo of equipment.Albuterol would not vaporize without it.Had to have someone come over on a saturday night.

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 8894623
• MDR Text Key: 154901420
• Report Number: MW5089051
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR