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

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Spontaneous inbound call from (b)(6), respiratory therapist to report that new altera replacement device is needed because patient's connection cord appears to be going bad.Date of event not reported.No missed doses and no adverse event/side effects or symptoms reported due to product problem.Not reported if product is available for return or not.No lot number or expiration date provided; no further information.Reported to (b)(6) by healthcare professional.

• Brand Name: ALTERA REPLACEMENT KIT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9995093
• MDR Text Key: 189153705
• Report Number: MW5094250
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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