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

Model Number 22 E

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

The carefusion field service engineer (fse) installed a new vmax encore 22 system at the customer¿s facility and performed system diagnostic test and noted after 20 min the pump would not pass the n2 gas calibration.The fse opened the module and adjusted the co2 analyzer and sample pump within specification.The unit passed gas calibration and the fse performed a successful self-lung-volume test.The 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).Carefusion file identification: (b)(4).

Event Description

The customer reported the sensor responded incorrectly to gas calibration during patient testing on the vmax encore 22 system.There was no report of patient injury associated with this event.The customer performed troubleshooting in conjunction with the carefusion technical support through the telephone; however, the issue was not resolved.A carefusion field service engineer (fse) was scheduled to inspect the unit at the customer's facility.

Manufacturer Narrative

Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed physical damages on the cover of the unit.Testing of the unit continued by performing atp test which failed gas calibration.The reported problem was duplicated and the co2 analyzer was determined to be faulty.Failure analysis technician replaced the co2 analyzer and retested gas calibration which passed.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.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• 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 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5173123
• MDR Text Key: 29339133
• Report Number: 2021710-2015-01999
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2006
• 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