MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. MICRO; SPIROMETER, DIAGNOSTIC

Model Number MICRO

Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085); Failure to Power Up (1476); Product Quality Problem (1506)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2017

Event Type  malfunction  

Event Description

A total of (b)(4) units over the last approximately 2 years that did not work when they arrived or were returned by the patients so we needed to swap them out.The devices either will not charge, hold a charge or power on after a full charge.This appears to be a quality control issue or product durability issue.

• Brand Name: MICRO
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 22745 savi ranch pkwy.; yorba linda CA 92887
• MDR Report Key: 6618131
• MDR Text Key: 76848781
• Report Number: 6618131
• Device Sequence Number: 1
• Product Code: BZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MICRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1