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

Model Number 3100A

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The customer reported that the ventilator failed the installation with an audible alarm continually sounds whether an alarm condition is present or not.No pt involvement.

Manufacturer Narrative

(b)(4).The customer evaluated the ventilator and determined that replacing the alarm board resolved the issue.

Manufacturer Narrative

The carefusion failure analysis technician examined the alarm board assy and found that along with a corresponding audible alarm, the hi paw led is coming on intermittently.Found that the output voltage at comparator ic u5 pin 14 is going low with no alarm condition.Duplicated the complaint allegation that the audible alarm continually sounds whether an alarm condition is present or not.This issue is being addressed in an internal correction.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• 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: 4504278
• MDR Text Key: 17297574
• Report Number: 2021710-2015-00222
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

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: 768901-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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