MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion failure analysis technician will evaluate the alleged failed part if it is returned to the manufacturer.(b)(4).

Event Description

The customer reported that the map is fluctuating.The min paw alarm alarms at 17.5 instead of 19cm when the map is set to 20cm on panel meter.During inspection found that mean pressure monitor would not maintain a stable reading, also noted that min.Paw thumbwheel switch did not alarm at proper setting.Switch was set to 20 cmh2o and when mean pressure was lowered below 20 unit should have alarmed unit did not alarm until reading 17.5 cmh2o on the mean pressure monitor.Noted pressure drop on mean pressure monitor when reading pressure on valves at bulkhead.Mean pressure was set to 41.1 cmh2o to take readings after removing tubing from fitting on bulkhead and reattaching to test pressure meter reading on mean pressure meter would drop to 35 cmh20.No patient involvement.

Manufacturer Narrative

Failure analysis (fa) lab received a 3100a alarm board.The fa lab performed an investigation and was unable to duplicate the reported issue, however the pressure monitor was out of calibration.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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 ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 8473628056
• MDR Report Key: 5094494
• MDR Text Key: 26646562
• Report Number: 2021710-2015-01705
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup,Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• 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-RNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2001
• 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