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

Model Number 3100B

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The customer was sent a replacement driver.As of this date it has not been received for evaluation.When it has been received and evaluated a supplement will be filed.

Event Description

The following description of the event was documented by a carefusion tech support specialist in a response to a phone conversation with a user facility representative on (b)(6) 2014.The customer called to report that the driver stopped while on a patient a couple of days ago.There was no patient compromise; they quickly switched the patient to another 3100b.The customer stated that all of a sudden the driver made a clunking noise and appeared to be moving, but the driver was stopped.The oscillator stopped light was not on, but the noise alerted the staff that there was a problem.

Manufacturer Narrative

Failure analysis (fa) lab received and examined a driver assembly.Fa found that the coil grinds when it is moved.The resistance is reading high and the coil is shorted into the pole piece.Fa disassembled the driver and found that the piston has been scraping on the pole piece.Fa duplicated the complaint allegation.The driver drags and the coil is damaged.The driver assembly was scrapped.

Manufacturer Narrative

The driver power module was fully evaluated but no failure was detected.The reported issue could not be duplicated so no root cause could be determined.However, the driver controller had physical damage at r1, r19.This component was transferred to the service department to replace the controller.If additional information becomes available, then a supplemental report will be filed.

• Brand Name: 3100B
• 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 ; 7607787307
• MDR Report Key: 5415580
• MDR Text Key: 38227740
• Report Number: 2021710-2016-02920
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2014

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: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 02/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/19/2016; 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1