• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2015
Event Type  Malfunction  
Manufacturer Narrative

Any additional information received from the customer will be provided in a follow-up report. (b)(4). Carefusion has not received the suspect device from the customer. Carefusion file identification: (b)(4).

 
Event Description

The customer reported low functional residual capacity (frc) while performing pulmonary function analysis on a patient using the vmax encore 22 instrument. Incorrect test results were generated and released to the physician; however, there was no patient impact associated with the event. The customer indicated the unit did not washout at an expected length of time and displayed spikes. Further system troubleshooting was performed, however a clear cause could not be confirmed. The customer received a new unit, and it is currently in full operation. No further issues were noted by the customer.

 
Manufacturer Narrative

An evaluation of the returned vmax encore unit was performed. Visual examination of the vmax module revealed no anomalies and/or physical damage. The vmax module was powered up and allowed to warm up for 30 minutes. After the warm-up, diagnostic display all functioned normally. The technician performed multiple gas calibrations and all calibrations passed without any issue. The technician noticed that during functional residual capacity (frc) test, the demand valve free flowed excessively, causing a leak during the test. The technician replaced the demand valve and retested frc which passed within specification. The technician also replaced the co2 analyzer and power supply as precautionary measures. It was noted that the co2 analyzer and power supply had no serial or lot number for traceability. The technician could not duplicate the ¿o2 blowing out of the back of the module¿ issue, noting possible external factors. The reported issue was duplicated. In conclusion, the likely cause of the event is attributed to the demand valve. However, a definitive root cause is unknown with the available information. Carefusion continues to track and trend any incident related to this issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5184440
MDR Text Key30066733
Report Number2021710-2015-02059
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 10/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777543-101
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 Received01/16/2016
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

-
-