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

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Spontaneous call from pt mom to report issues with cord staying connected to handset.She stated that if child bumps cord even lightly, cord will come out of handset, causing it to take longer to administer medication.No further information provided.Mom will contact manufacturer as well dosing information: reconstitute with provided diluent and inhale the contents of 1 vial via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Reported to (b)(6) by pt/caregiver.

• Brand Name: HANDSET ALTERA
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9910388
• MDR Text Key: 186182191
• Report Number: MW5093998
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• 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