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

Model Number 3100 A

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.(b)(4).The carefusion field service representative went onsite to evaluate the suspect device.The field service rep confirmed the customer's alleged issue when pushing the start/stop button with system pressurized, the drive does not turn on.The field service rep swapped out the ddi (dynamic displacement indicator) board and did ddi adjustments and noted the start/stop button is now working every time.The field service rep reported the unit is working to correct specifications and reported the device has been repaired and returned to the customer.At this time, the defective ddi board has been received by carefusion failure analysis lab and is awaiting investigation.Upon the completion of the investigation, a supplemental report will be submitted.

Event Description

The customer reported while using the 3100 high frequency oscillating ventilator (hfov), when pushing the start/stop button when the system is pressurized, the driver does not turn on.The customer reported that the issue occurs intermittently.There is no report of patient involvement associated with the event.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis representative (fsr) examined the suspect 3100 a pcba (printed circuit board assembly) and found that the ic (in-circuit) u7 pin 1 does not always toggle with changes to the input on pin 3.The fsr was able to duplicate the customer's reported issue and determined the root cause to be a defective ic u7, the output of pin 1 does not always toggle with changes to the input on pin 3.This issue will be internally investigated within carefusion.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5505820
• MDR Text Key: 40679351
• Report Number: 2021710-2016-03353
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

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: Other Health Care Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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