MAUDE Adverse Event Report: CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 229 E

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

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.

• Brand Name: VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
• Type of Device: CALCULATOR, 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 Key: 5186011
• MDR Text Key: 30219401
• Report Number: 2021710-2015-02075
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 229 E
• Device Catalogue Number: 777400-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 54