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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number VMAX MODEL 29C E
Device Problems Transformer (523); Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271); Environmental Compatibility Problem (2929); Power Problem (3010)
Patient Problems Dizziness (2194); Thromboembolism (2654)
Event Date 06/24/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A follow-up call with the reporter determined that she had her facilities team confirm that there were no electrical faults within the wall sockets she had used. A cfn field service representative was dispatched to assess the situation and he confirmed the presence of discoloration on the prongs of the ac power cord. He replaced the power cord and the isolation transformer as a precautionary measure and tested the system. The vmax system functioned as intended after the transformer and cord replacement. The isolation transformer and the power cord were returned to cfn for evaluation. Discoloration was observed on the prongs of the cord as previously confirmed. A visual examination of the isolation transformer revealed signs of physical damage to the outer case. Internally two sets of connectors were found to be unplugged. There were no signs of internal discoloration or other physical damage noted. Testing of the power cord revealed no further anomalies and the transformer was powered up with the returned power cord and tested under full load conditions with no evidence of overheating or malfunction.

 
Event Description

It was reported to the carefusion technical support representative by the clinician at the user facility that they came in to find that the vmax system had been moved with the power off. They usually do not power the system off. She then stated "the plug in the wall from the cart was plugged in and she noticed it was sparking, she unplugged it and it sparked again. " she then moved it to another outlet and that sparked too when she plugged it in.

 
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Brand NameCAREFUSION
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
8473628056
MDR Report Key4936863
MDR Text Key22581820
Report Number2021710-2015-01253
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX MODEL 29C E
Device Catalogue Number777409-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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