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

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The customer reported that he is having a hard time centering the piston and the driver seems to lose amplitude etc.He then said he was trying to center it and after having to center it a few times while running, the driver just stopped.It alarmed correctly.No pt involvement.

Manufacturer Narrative

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

Manufacturer Narrative

The carefusion failure analysis engineer examined the driver and found that the coil ohms read 33 ohms and not the expected 3 ohms.Traced issue to a bad solder joint at the driver cable assy.Duplicated the customer complaint allegation.

• 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: wendy schumacher ; 7607787219
• MDR Report Key: 4804396
• MDR Text Key: 5919452
• Report Number: 2021710-2015-01050
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1999
• 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