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

Model Number 3100B

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Should any additional information be received by the customer then an additional report will be submitted.(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.

Event Description

The customer reported that this 3100b high frequency oscillating ventilator (hfov) was being used on a patient when the driver unexpectedly stopped.The device alarmed and the hfov was removed from the patient and alternate ventilation was provided by placing a known good unit on the patient.After the suspect unit was removed from the patient, the customer reported that the unit failed the patient circuit calibration.The customer stated that there was no patient injury or harm associated with this event.

Manufacturer Narrative

The 3100b ventilator was due for the 6 year and 7 year preventative maintenance.A carefusion field service representative (fsr) arrived onsite to evaluate the device, however, the customer opted to not have the preventative maintenance procedures performed on the unit.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING 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 ; 7149227830
• MDR Report Key: 5804616
• MDR Text Key: 49877519
• Report Number: 2021710-2016-04088
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• 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