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

Model Number 3100A

Device Problems Imprecision (1307); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/26/2014

Event Type  malfunction  

Event Description

The oscillatory ventilator was in use on a patient.The delta p was fluctuating significantly.A delta p of 30 was set, but a delta p of 18 was measured on the display.The patient circuit was changed.The delta p was still fluctuating from 20's - 30's.A similar complaint on this ventilator had occurred about a year ago, but no problem was found at the time.This time the problem was reproduced in clinical engineering after running for about an hour.The front panel amplitude meter was replaced.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 3772245
• MDR Text Key: 4357078
• Report Number: 3772245
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 3100A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 DAY
• Patient Weight: 2