STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 777401-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 777401-101 manufactured by Carefusion, Inc.

Event Text Entries

[68014750] (b)(4). The carefusion technical support assisted the customer with performing firmware upgrade which solved the stopping issue. Due to the event being resolved by upgrading the firmware; no parts will be sent back to carefusion.
Patient Sequence No: 1, Text Type: N, H10


[68014751] The customer reported while using the vmax encore device, the treadmill would stop during use. The issue occurred during patient use but no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2017-05437
MDR Report Key6340693
Date Received2017-02-17
Date of Report2017-02-17
Date of Event2017-02-06
Date Mfgr Received2017-02-06
Device Manufacturer Date2011-09-01
Date Added to Maude2017-02-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 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 Received2017-02-17
Model NumberVMAX ENCORE
Catalog Number777401-101
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-17

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