MAUDE Adverse Event Report: CAREFUSION SENSORMEDICS 3100B; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problems Device Operates Differently Than Expected (2913); Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

Rn was in patient room.High frequency oscillating ventilator started alarming and turned off.Rn notified rt and md and began ventilating the patient with ambu bag.Rn then switched the patient to the regular ventilator with no problems.

• Brand Name: SENSORMEDICS 3100B
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5063776
• MDR Text Key: 25232698
• Report Number: 5063776
• 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: Other
• Report Date: 08/05/2015

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2015
• Device Model Number: 3100B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES WERE IN USE THAT MAY HAVE CAUSED
• Patient Age: 58 YR