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

MAUDE Adverse Event Report: CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 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 VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 229 E
Device Problem Connection Problem
Event Date 09/17/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Once the device is returned for evaluation and additional information is received a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).

 
Event Description

The customer reported experiencing computer freeze-ups that were occurring 2-3 times a week. During a treadmill test, one of their protocol settings was not transferred correctly. The treadmill speed was supposed to be set at 0. 6 mph and it jumped up to 2. 5 mph on an elderly lady. She did not fall nor was there any incident resulting from this as the therapist was able to manually decrease the speed.

 
Manufacturer Narrative

An evaluation was performed by a carefusion failure analysis technician on the dell xe2 computer. The reported complaint was duplicated by powering up the computer and the screen showed ¿windows could not start because of a computer disk hardware configuration problem. ¿ this behavior was found to occur if the default value in the boot. Ini file is missing or invalid, windows xp is not installed in the location specified in the boot. Ini file, the ntoskrnl. Exe file is missing or damaged, the partition path in the boot. Ini file is not set correctly or because of a general hardware failure. In conclusion, it was determined that there was an issue with the hardware configuration.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
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 north fairway drive
vernon hills , IL 60061
8473628056
MDR Report Key5186011
Report Number2021710-2015-02075
Device Sequence Number1
Product CodeBTY
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial,Followup
Report Date 10/12/2015
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 Number229 E
Device Catalogue Number777400-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-