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

Model Number 3100A

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion field service technician evaluated the ventilator and found zero and span off slightly.Adjusted.Tested all alarms.All working (min max paw, low source, power failure and more).45 second alarm was at 50 seconds (within specs).Verified voltage psu, ddi board and pneumatics ok.Unable to duplicate "no alarms".Vent working within manufacturer's specs.Ran vent for an hour without issues.(b)(4).

Event Description

The customer reported that the alarms are not working properly.No patient involvement.

• 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 60061 ; 8473628056
• MDR Report Key: 5032616
• MDR Text Key: 24992117
• Report Number: 2021710-2015-01481
• 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
• Report Date: 07/29/2015

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: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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