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 02/27/2015

Event Type  malfunction  

Event Description

The customer reported that the ventilator alarm silence is out of specification.Its at 56 seconds and the most it should be in 53 seconds, 45 +8/6.No patient involvement.

Manufacturer Narrative

Evaluation by the carefusion failure analysis technician is anticipated but has not yet begun.

Manufacturer Narrative

The carefusion failure analysis technician examined the alarm pcba and found that the alarm silence circuit is taking 57 seconds to reset.Evaluated ic, u13 lm555 timer circuit and found that although capacitor c27 100uf 5% 20vreads the correct value, it is not charging in the specified time range.Replaced c27 with a known good capacitor and found that the circuit now operates per the specifications.Installed the suspected bad c27 capacitor on a known good alarm pcba and now this pcba fails the alarm silence time test.Finding/root-cause: duplicated, the alarm silence is out of spec., complaint allegation.Defective capacitor c27 alarm pcba.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 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: 4649647
• MDR Text Key: 5595802
• Report Number: 2021710-2015-00640
• 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,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

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-RNT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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