STATIC AND DYNAMIC COMPLIANCE 777404-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-18 for STATIC AND DYNAMIC COMPLIANCE 777404-101 manufactured by Vyaire Medical, Inc.

Event Text Entries

[105870760] The reported issue was due to the patient falling on the mass flow sensor and breaking it. No further investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10


[105870761] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2018-07742
MDR Report Key7441966
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-04-18
Date of Report2018-04-18
Date of Event2018-04-16
Date Mfgr Received2018-04-16
Device Manufacturer Date2017-01-01
Date Added to Maude2018-04-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN GRAF
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer G1VYAIRE MEDICAL, INC
Manufacturer Street1100 BIRD CENTER DR.
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTATIC AND DYNAMIC COMPLIANCE
Generic NameCALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2018-04-18
Catalog Number777404-101
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-18

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