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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION VMAX CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION 207, INC. DBA CAREFUSION VMAX CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Device Problems Sensor (510); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2016
Event Type  Malfunction  
Event Description

Oxygen sensor not working correctly resulting in erroneous results. Three patients needed to be retested. No patient harm.

 
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Brand NameVMAX
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION 207, INC. DBA CAREFUSION
1100 bird center dr.
palm springs CA 92262
MDR Report Key6056949
MDR Text Key58381152
Report Number6056949
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2016
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2016
Event Location Hospital
Date Report TO Manufacturer09/12/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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