MAUDE Adverse Event Report: CAREFUSION 3100A; VENTILATOR, HIGH FREQUENCY

Model Number 3100A - UPGRADE

Device Problem Calibration Error (1078)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number: (b)(4).In the event the unit becomes available for evaluation or additional information becomes available a follow-up report will be submitted.(b)(4).At this time, carefusion has not received the device from the customer.

Event Description

The customer stated: "the "fz" meter iis only reading 1 when all the way to the right and it won't adjust.When the "fz" knob is turned, the "fz" changes so he believes the display is faulty.There was no patient involvement, the event occurred during calibration.".

Manufacturer Narrative

Device evaluation: the field service representative evaluated the unit and determined the root cause to be due to a defective power module driver.The driver was replaced and the unit was placed back in service.A return material authorization was issued for the power module driver where the factory service department performed maintenance on the power module driver and the unit is now meeting factory specifications.

• Brand Name: 3100A
• 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 ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5154886
• MDR Text Key: 28723536
• Report Number: 2021710-2015-01907
• 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: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100A - UPGRADE
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1