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

Model Number 3100A

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.The device was returned to the rental facility and passed the safety performance inspection.The unit operated per specifications after the rental facility's repairs.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 while the device was on a patient, the customer noticed that the patient was not oxygenating despite the blender dial being set on 100% o2.The ventilator was performing to specification, but the customer noticed that the knob was very "loose".The customer put an external analyzer in-line and confirmed that the delivered fio2 was not 100%.There was no patient compromise.The patient was placed on another ventilator.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATORVENTILATOR, HIGH FREQUENCY, 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: 5902819
• MDR Text Key: 52941753
• Report Number: 2021710-2016-04292
• 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: 07/27/2016

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: 3100A
• Device Catalogue Number: 768901-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2007
• 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