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

Catalog Number 777404-101

Device Problem Break (1069)

Patient Problem Fainting (1847)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

The reported issue was due to the patient falling on the mass flow sensor and breaking it.No further investigation will be performed.

Event Description

The customer reported while using the vmax encore the patient performed a valsalva maneuver, experienced syncope and fell down.The customer reported that the patient grabbed the mass flow sensor while falling thus breaking it.The patient was sent to the emergency room as a precaution and no injury was noted at the time of the event.A replacement mass flow sensor was sent to the customer as a resolution.

• 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: 7441966
• MDR Text Key: 105870760
• Report Number: 2021710-2018-07742
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2017
• 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
• Patient Outcome(s): Other