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

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Patient's mom, (b)(6), reported current device is falling apart.Solicited call.No additional information.We have never shipped this to patient.Unknown where pt got from in the past.Unknown if missed any doses or if experienced any adverse events.Indication: pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified else\ml ere and cystic fibrosis with pulmonary manifestations.Reported (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9943272
• MDR Text Key: 187194541
• Report Number: MW5094088
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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
• Patient Sequence Number: 1