MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion failure analysis engineer examined the 3100b ventilator and found that, it is functioning normally.Calibrated known good patient circuit to this unit then the unit was set-up per the unit¿s top cover ventilator performance checks label.Unit was then operated, on and off, for two weeks.It was observed that the unit operated within the prescribed parameters during the entire test with no problems.Removed covers from unit and could find no problems.Check power supply voltages and found no problems.Could not duplicate the complaint allegation that there was a loud noise and the ventilator shut down.(b)(4).

Event Description

The customer reported that while in patient use the ventilator shut down.They quickly replaced the circuit thinking there was a leak, but were not able to power the machine back on.They did not notice "alarms," but did state they were alerted to the incident.She was told that the patient was transferred to a conventional ventilator and there was no patient compromise.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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 ; 8473628056
• MDR Report Key: 5078191
• MDR Text Key: 25882952
• Report Number: 2021710-2015-01643
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 773967-RNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention