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

Model Number 3100A

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 04/14/2019

Event Type  malfunction  

Event Description

During cares the patient became disconnected from the ventilator.No alarm sounded.On closer inspection, the 45 sec silence button was illuminated and stayed illuminated greater than two minutes.The ventilator was removed from patient use and replaced with a new oscillator.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH-FREQUENCY
• Manufacturer (Section D): CAREFUSION CORPORATION; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 8914988
• MDR Text Key: 155048717
• Report Number: 8914988
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2019,08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA