MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA HANDSET (NO COST); NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient¿s sister reported patient is a month behind taking medication due to them not having the device.Unknown number of missed doses.Device is being sent out for tomorrow.No adverse effects reported.Spontaneous call.Unknown what happened to first device that was supposed to be sent out or if product on hand for return.No additional information.Indication: pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere, tracheostomy status, other specified respiratory disorders, acute tracheitis without obstruction, unspecified infectious disease, acute tracheitis, and other bacterial infections of unspecified site.Reported to (b)(6) by: patient/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 11011446
• MDR Text Key: 221834094
• Report Number: MW5098371
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1