STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 29 UNIT ASSEMBLY 777497

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 2016-10-13 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 29 UNIT ASSEMBLY 777497 manufactured by Carefusion, Inc.

Event Text Entries

[57397600] (b)(4). No device or parts will not be returned to carefusion for evaluation at this time as the reported issue seems to be due to a software upgrade. The customer performed the software upgrade and the reported issue was resolved.
Patient Sequence No: 1, Text Type: N, H10


[57397601] The customer reported that the treadmill has been stopping during testing while in use on a patient and using the cardio v6. 51 cam14 with usb.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2016-04637
MDR Report Key6028289
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-10-13
Date of Report2016-09-20
Date of Event2016-09-20
Date Mfgr Received2016-09-20
Device Manufacturer Date2009-01-02
Date Added to Maude2016-10-13
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 ContactJILL RITTORNO
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149227830
Manufacturer G1CAREFUSION, INC
Manufacturer Street1100 BIRD CENTER DRIVE
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, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2016-10-13
Model NumberVMAX ENCORE 29 UNIT ASSEMBLY
Catalog Number777497
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-10-13

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