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

Model Number 3100B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Respiratory Failure (2484)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.The customer returned the 3100b ventilator to a rental facility.The rental facility was not able to duplicate the reported issue.The rental facility performed a safety performance inspection and the ventilator passed the inspection.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the start/stop button on this ventilator does not work.The user tried to re-pressurize the ventilator and restart the piston, but was not able to.The patient was being suctioned at the time the reported issue occurred and there was a delay in returning the patient to the ventilator, which caused a prolonged recovery time.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCYVENTILATOR, 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 ; 7149227830
• MDR Report Key: 5948270
• MDR Text Key: 54625448
• Report Number: 2021710-2016-04405
• 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: 08/16/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2001
• 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
• Patient Outcome(s): Required Intervention