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

Catalog Number 777400-102

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint #: (b)(4).Results of investigation: the vyaire factory service (fs) technician received the suspected device and performed a failure investigation.The reported issue was confirmed.The device would not power on.Also, a burnt analyzer board and solenoid cable were found during the investigation.It is unknown what the root cause of the failure is.

Event Description

The customer reported that the vmax module absolutely failed to power on.There was no patient involvement at the time of the reported issue.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED 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: 6994319
• MDR Text Key: 91201666
• Report Number: 2021710-2017-06905
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2017

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: Other
• Device Catalogue Number: 777400-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2004
• 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