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

Device Problem Break (1069)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Pt uses the altera device to administer her cayston medication 75 mg three times a day for 2 weeks on and 2 weeks off.Ndc for cayston is 61958-0901-01.Pt stated the machine broke that she uses to initiate her cayston.No add'l info.Pt did not report any adverse events, unk if she missed any doses, has the device on hand for investigation or if she had a backup.New device shipped 03/03/2020.Product lot number and expiration date unk.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9853376
• MDR Text Key: 184522816
• Report Number: MW5093842
• 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: 03/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Patient Sequence Number: 1
• Patient Age: 62 YR