MAUDE Adverse Event Report: VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION

Model Number PHYSICIANS CHOICE ENCORE

Device Problem Calibration Problem (2890)

Patient Problem No Information (3190)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As the correction for this event, the vyaire medial field service engineer installed a replacement module during an onsite visit.Results of investigation: the suspected device was received and a failure investigation was performed.The reported issue was confirmed and a burnt analyzer board was found.Upon further investigation, the failure analysis technician found there was shorted to ground by the pneumatic control board assembly mounting hardware.Several attempts have been made to contact the customer for additional information.At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue.

Event Description

The customer initially reported the static and dynamic compliance vmax device was showing lower than expected residual volume values.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7539370
• MDR Text Key: 109105936
• Report Number: 2021710-2018-07897
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

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: Health Professional
• Device Model Number: PHYSICIANS CHOICE ENCORE
• Device Catalogue Number: 777544-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1