STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101 manufactured by Carefusion, Inc.

Event Text Entries

[70316847] (b)(4). Device evaluation: a vyaire field service representative (fsr) was dispatched to evaluate the system. The fsr was unable to duplicate the reported problem. After review of computer logs, it was determined anti-virus software scanned during patient testing, then a computer error occurred. The customer was provided information regarding the use of the product and anti-virus software scanning and that scanning must be disabled during patient testing.
Patient Sequence No: 1, Text Type: N, H10


[70316848] The customer reported that while using the static and dynamic compliance, the track master treadmill dom 220v stopped while performing an exercise study on a patient. The customer reported that there was no patient harm or injury associated with the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2017-05602
MDR Report Key6411085
Date Received2017-03-16
Date of Report2017-03-16
Date of Event2016-12-21
Date Mfgr Received2016-12-27
Device Manufacturer Date2003-04-01
Date Added to Maude2017-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
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 G1CAREFUSION, 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 Report0

Device Details

Brand NameSTATIC AND DYNAMIC COMPLIANCE
Generic NameCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2017-03-16
Model NumberVMAX ENCORE 22
Catalog Number777404-101
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-16

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