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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problem Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2015
Event Type  Malfunction  
Manufacturer Narrative

The carefusion field service engineer (fse) installed a new vmax encore 22 system at the customer¿s facility and performed system diagnostic test and noted after 20 min the pump would not pass the n2 gas calibration. The fse opened the module and adjusted the co2 analyzer and sample pump within specification. The unit passed gas calibration and the fse performed a successful self-lung-volume test. The unit conformed to the manufacturer¿s published performance specifications and was returned to normal operation. Carefusion continues to track and trend any incident related to this issue. (b)(4). Carefusion file identification: (b)(4).

 
Event Description

The customer reported the sensor responded incorrectly to gas calibration during patient testing on the vmax encore 22 system. There was no report of patient injury associated with this event. The customer performed troubleshooting in conjunction with the carefusion technical support through the telephone; however, the issue was not resolved. A carefusion field service engineer (fse) was scheduled to inspect the unit at the customer's facility.

 
Manufacturer Narrative

Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed physical damages on the cover of the unit. Testing of the unit continued by performing atp test which failed gas calibration. The reported problem was duplicated and the co2 analyzer was determined to be faulty. Failure analysis technician replaced the co2 analyzer and retested gas calibration which passed. In conclusion, the likely cause of the event is attributed to the co2 analyzer. However, a definitive root cause is unknown. Carefusion continues to track and trend any incident related to this issue.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
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 n. fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key5173123
MDR Text Key29339133
Report Number2021710-2015-01999
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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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