MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION 3100B; HIGH FREQUENCY OSCILLATING VENTILATOR

Model Number 3100B

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Pulmonary Edema (2020)

Event Date 08/19/2015

Event Type  malfunction  

Event Description

Patient had pulmonary edema with a considerable amount of fluid in the tubing.Rn returned to find pt.Being suctioned and oscillator alarming and not running.The differential pressure (delta p) was reading 0 cmh2o and the mean airway pressure (map) was 112 cmh2o.The oscillator would not restart after several attempts.Biomed was able to verify the device would not start.After troubleshooting further, it was noticed that the patient sensing line filter was creating the issue.With the filter removed from the line, the oscillator restarted and functioned normally.The pt.Was a (b)(6) on the adult oscillator (3100b) with lower than usual settings, but still within normal operating range.Typical adult delta p is 80 and this pt.Had 60.It was determined that either the sensing line pressure or a saturated filter was the root cause for stopping the oscillator.Biomed performed tests on the device to ensure it was operating correctly.Respiratory updated their process to swap out filter every 24 hours.This will mitigate a wet filter stopping the oscillator or moisture reaching and damaging the transducer circuit board.Manufacturer response for high frequency oscillating ventilator, 3100b high-frequency oscillatory ventilator (per site reporter): as of this report, the manufacturer has not responded.

• Brand Name: 3100B
• Type of Device: HIGH FREQUENCY OSCILLATING VENTILATOR
• Manufacturer (Section D): CAREFUSION 207, INC. DBA CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 5031072
• MDR Text Key: 24090113
• Report Number: 5031072
• 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: 08/20/2015

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 Model Number: 3100B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• 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: A FILTER IS ON THE PATIENT SENSING LINE OF THE OSC
• Patient Outcome(s): Other
• Patient Age: 15 YR