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

Model Number 3100B

Device Problem Increase in Pressure (1491)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.At this time, carefusion has not received the device from the customer.(b)(4).

Event Description

Carefusion received the user facility/importer medwatch report on (b)(6) 2015 where the customer stated that during high frequency oscillatory ventilation, the respiratory care practitioner noted that the indicator for deltap climbed from 30 deltap to 140 deltap on the front panel indicator and the ventilator began alarming.The respiratory care practitioner could not control the climbing deltap indication by correction power or pressure adjustments.The patient airway pressure remained at 20.5 cm h2o and the patient's chest movements seemed "normal." the biomed department was contacted to assist in exchanging the ventilator and the problem ventilator was sent to the biomedical for repair analysis.The biomed troubleshot the unit and noted fluid buildup and pooling near the internal differential pressure transducer and static pneumatic tubing loop.It was also noted that this was the third failure of this type in the last four months.The biomed cleared and flushed the tubing and transducer and retested the oscillator to normal operation and performance.After further investigation, the customer reported that the ventilator was exchanged and no there was no patient harm or injury.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22475 savi ranch pkwy; yorba linda, CA 92887 ; 7149229830
• MDR Report Key: 5299151
• MDR Text Key: 33582618
• Report Number: 2021710-2015-02463
• 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: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/17/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/15/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention