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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 Consequences Or Impact To Patient (2199)
Event Date 10/20/2015
Event Type  Malfunction  
Manufacturer Narrative

Carefusion file identification: (b)(4). Patient demographics such as age, date of birth, gender, and weight were not provided by the customer. The carefusion field service engineer (fse) went on site to adjust co2 analyzer but the system still would not calibrate. The fse came back and installed a new vmax encore 22 system at the customer¿s facility and performed system verification. The new 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).

 
Event Description

The customer reported having high frc during patient testing on the vmax encore 22 system; the customer has not performed a gas calibration before. The incorrect results were released to the physician; however the physician noticed the incorrect results. There was no report of patient impact associated with this event. The carefusion technical support (ts) explained to the customer on how to perform gas calibration and noted it failed twice after completing. The ts completed a diagnostic test on the unit and noted that the co2 baseline was high and did not increase to 1. 6 volts. A carefusion field service engineer was scheduled to inspect the unit at the customer's facility and the customer will ordered a new replacement module.

 
Manufacturer Narrative

Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed no anomalies and physical damage. Testing of the unit continued by powering up the unit, and allowed to warm-up for 30 minutes. After 30 minutes, n2 calibration was performed, however the unit continued to fail. The c02 analyzer measured slope is < 0. 5 or greater than 1. 5. The slope on the lamp was too high. Investigation concludes that the co2 analyzer was determined to be faulty. The faulty c02 analyzer was replaced which resolved the reported issue. 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 Key5219018
MDR Text Key31132257
Report Number2021710-2015-02177
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
Report Date 10/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777404-101
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 Received10/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2015
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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