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

Model Number 3100A

Device Problems Component Falling (1105); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch report was identified as a late submission during a two year retrospective review of complaints and following receipt of an untitled letter issued by the fda.The carefusion went onsite and found that the vent will alarm all the time even with map on 15.The fse replaced the alarm board and performed all alarm function testing and ovp / uvt.Vent working as per specifications.As of this date the part 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 and reported that the driver stops for no apparent reason.The map holds and then falls.Once the map falls below the low alarm setting the unit alarms.There was no patient compromise; they quickly switched the ventilator out.

Manufacturer Narrative

Additional information: failure analysis (fa) lab received an alarm board assembly (3100a).The fa lab performed an investigation and was able to duplicate the reported issue.The alarm function checkout failed.The failure at alarm led (paw> 50cmh2o): alarm led was on all the time.The output pin u5.13 was stuck in high level.

• Brand Name: 3100A PRODUCT
• 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: marshall thompson ; 7607787307
• MDR Report Key: 5416969
• MDR Text Key: 37726631
• Report Number: 2021710-2016-03002
• 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
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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: 09/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1