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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 229C E
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2015
Event Type  Malfunction  
Manufacturer Narrative

The carefusion file identification number is (b)(4). At this time the device is functioning as intended and is in normal operation. Carefusion continues to track and trend any incident related to this issue. (b)(4).

 
Event Description

It was reported by the customer that while doing a test the treadmill abruptly stopped. It went from a speed of 2 miles per hour and a grade of 10. 5 to zero. There was no patient harm or injury reported. A carefusion field service technician (fst) inspected the treadmill and all of its connections and ran a test protocol study without issue. All factors and settings were found to be within specifications. It was determined that there were network issues at the facility which caused the loss of communication between the device and the treadmill.

 
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Brand NameVMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
jill rittorno
75 north fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key5212810
MDR Text Key31016989
Report Number2021710-2015-02172
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK942211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 10/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number229C E
Device Catalogue Number777410-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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