MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion will evaluate the alleged failed part if it is returned to the mfr.

Event Description

The customer reported that the ventilator is not starting again when the start/stop button is depressed.The duty cycle and frequency are blank.Ventilator could not start.No data in inspiratory time and frequency_hz window.

• Brand Name: CAREFUSION
• 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: 5014923
• MDR Text Key: 23945726
• Report Number: 2021710-2015-01416
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Report Date: 07/24/2015

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: 768909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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