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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION Back to Search Results
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.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, 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 Key7441966
MDR Text Key105870760
Report Number2021710-2018-07742
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
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
Date FDA Received04/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number777404-101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/18/2018 Patient Sequence Number: 1
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