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

Model Number 3100B

Device Problems Thermal Decomposition of Device (1071); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results of investigation: the carefusion failure analysis laboratory received the suspect component, a 3100b driver assembly, and evaluated the device.An evaluation of the component duplicated the reported issue and isolated the issue to a pole piece being out of place which caused the coil assembly to become damaged and burned.

Event Description

The customer reported that the mean airway pressure dropped and caused the driver on the unit to stop while the unit was in use on a patient.The ventilator alarmed and the user hand-ventilated the patient while troubleshooting the issue.There was no patient compromise.The user found the red cap diaphragm loose and replaced it.The user quickly re-pressurized the unit and restarted the ventilator.After a few minutes, the user started to hear a high pitched "squeak" with every beat of the ventilator.The user tried to ignore the "squeaking" as the settings were stable.After a few minutes, the user smelled an "electrical burning smell." the nurses felt the smell was coming from the back of the ventilator.There was no indication of any problems with the unit.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6254392
• MDR Text Key: 64916689
• Report Number: 2021710-2017-05248
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 773967-RNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2014
• Initial Date FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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