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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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Calibration Problem (2890)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2015
Event Type  Malfunction  
Manufacturer Narrative

The field service engineer (fse) assessed the unit and noted the analyzer responded incorrectly to gas calibration and verified gas tank pressures. The fse discovered a faulty oxygen (o2) cell sensor and replaced the senor to resolve the reported issue. The fse then allowed the unit to warm up and re-verified all o2 responses returned to normal ranges. The fse performed a functional residual capacity (frc) calibration and it passed within specifications. An frc validation procedure was also performed and completed at 98% of target. The customer indicated the questioned device will not be returned to carefusion. The unit was returned to normal operation. No further issues were noted by the customer. (b)(4). In conclusion, the likely cause of the event is attributed to the o2 cell sensor. However, a definitive root cause is unknown with the available information. Carefusion continues to track and trend any incident related to this issue.

 
Event Description

The customer reported gas calibration issue while using the vmax encore 22 pulmonary function analysis instrument. A patient was being tested at the time of the reported issue, and test results were generated and released to the physician. The customer then noticed the results were erroneous and informed the physician; the results were not used in making a diagnosis. The customer stated there was no patient impact associated with this event. A field service engineer (fse) was dispatched to assess instrument.

 
Manufacturer Narrative

Additional information from field service: the field service engineer (fse) verified the issue with o2 cell - reading at 0. 100 with the pump on. The fse removed the faulty o2 cell and installed a new o2 cell. The fse allowed the unit to warm up then performed verifications - all o2 responses returned to normal. The fse performed functional residual capacity (frc) analyzer calibration and it passed multiple times. The fse performed frc validation procedure and it was 98% of target.

 
Manufacturer Narrative

Device evaluation: an evaluation of the returned device was performed. Visual inspection of the received o2 analyzer assembly noted no issues. The service technician connected the o2 analyzer to a known good vmax test unit and noted the o2 reading did not change after o2 was supplied. The technician confirmed it failed the analyzer calibration per lung volumes test, per the manufacturing procedure. The reported issue was able to be duplicated. In conclusion, the likely cause of the event is attributed to the o2 analyzer assembly. 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 Key5248525
MDR Text Key32204310
Report Number2021710-2015-02323
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777543-102
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 Received02/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2010
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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