MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. PARI LC SPRINT NEBULIZER SET; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/01/2019

Event Type  malfunction  

Event Description

Pt reported the pari lc sprint nebulizers he recently received are not working, medication is not coming out of his nebulizer machine like previous fills.He received 4 nebulizer kits in the mail and he tried all 4 of them and none are working properly.

• Brand Name: PARI LC SPRINT NEBULIZER SET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9530115
• MDR Text Key: 173192528
• Report Number: MW5091931
• Device Sequence Number: 4
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR