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

Model Number 3100A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion will evaluate alleged failed product if returned to the mfr.

Event Description

The customer reported that the circuit calibration and the performance check come in fine on this unit.He said the rt's noticed the adjust knob doesn't seem to be where it is normally set during the calibration.No pt involvement, found during calibrations.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION ; yorba linda CA
• Manufacturer (Section G): CAREFUSION ; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway dr. ; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5014914
• MDR Text Key: 23946856
• Report Number: 2021710-2015-01417
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• 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
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• 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