VYAIRE V-892392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for VYAIRE V-892392 manufactured by Vyaire Medical Gmbh.

Event Text Entries

[145902874] The patient came for a pulmonary function test (pft). When the patient got home, he called the lab and stated that he had coughed and expectorated a piece of plastic. The patient was called to see how they were doing, and the patient sent a photo of the piece of plastic which resembles the plastic wrapper for the mouthpiece filter. The mouthpiece is the interface between the pft machine and patient and incorporates a hepa filter between. They are single patient use, disposable items. We have a copy of the picture.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8632928
• MDR Report Key: 8632928
• Date Received: 2019-05-22
• Date of Report: 2019-05-10
• Date of Event: 2019-02-20
• Report Date: 2019-05-10
• Date Reported to FDA: 2019-05-10
• Date Reported to Mfgr: 2019-05-22
• Date Added to Maude: 2019-05-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VYAIRE
• Generic Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Product Code: CAH
• Date Received: 2019-05-22
• Model Number: V-892392
• Catalog Number: V-892392
• Lot Number: 182415-38
• Device Availability: N
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VYAIRE MEDICAL GMBH
• Manufacturer Address: 26125 N. RIVERWOODS BLVD METTAWA IL 60045 US 60045

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-22