MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION SENSORMEDICS; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2015

Event Type  malfunction  

Event Description

During high frequency oscillatory ventilation, the respiratory care practitioner (rcp) noted that the indicator for deltap climbed from 30 delta p to 140 deltap on the front panel indicator and the ventilator began alarming.The rcp could not control the climbing deltap indication by correcting power or pressure adjustments.The patient airway pressure remained at 20.5cm h20 and the patient's chest movements seemed "normal".Biomedical was contacted to assist in exchanging the ventilator and the problem ventilator was sent to biomedical for repair failure analysis.Bmet troubleshooting noted fluid buildup and pooling near the internal differential pressure transducer and static pneumatic tubing loop.Bmet noted that this was the third failure of this type in the last 4 months.Failure was noted on the adult version of the oscillator ventilator.Bmet cleared and flushed the tubing and transducer and retested the oscillator to normal operation and performance.Bmet contacting manufacturer with failure details for additional investigation.Manufacturer response for oscillatory ventilator, sensormedics (per site reporter): awaiting manufacturer response.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION 207, INC. DBA CAREFUSION; 1100 bird center dr; palm springs CA 92262
• MDR Report Key: 5219677
• MDR Text Key: 31018053
• Report Number: 5219677
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3100B
• Other Device ID Number: 5038 HOURS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2015
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HEATED HUMIDIFIER