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

Device Problem Break (1069)

Patient Problem Missed Dose (2561)

Event Date 10/29/2020

Event Type  malfunction  

Event Description

Spontaneous initial call from patient to report the machine broke and he needs a replacement; he advised that machine broke on (b)(6) 2020, which is when he took his last dose; next dose was due on (b)(6) 2020 and patient has not received replacement device yet, so doses were missed, but no side effects reported as a result; unknown if patient has defective device on hand; no lot number or expiration date provided; no further information.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: 10792839
• MDR Text Key: 215088765
• Report Number: MW5097670
• 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: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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
• Patient Age: 29 YR