MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA DEVICE STARTER KIT; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Pt reported her device is not working and she needs a new one.Solicited call.(b)(6) did not dispense the device initially.No add'l info.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA DEVICE STARTER KIT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9266310
• MDR Text Key: 165094085
• Report Number: MW5090827
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1