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

Model Number 3100A

Device Problems No Audible Alarm (1019); Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion field service engineer evaluated the ventilator and was unable to duplicated the reported failure.The unit was checked thoroughly for pressures, settings, alarms, etc and no issues were found.Unit passed all company specs using standard ridged circuit and also with the flexible circuit.No reason for the failure to alarm could be found.(b)(4).

Event Description

The customer reported that while in patient use the ventilator shut down and the unit did not alarm.Pt was placed on another 3100a, no patient harm.

• 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: 5078235
• MDR Text Key: 25880805
• Report Number: 2021710-2015-01646
• 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: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• 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: 06/01/2003
• 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