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

Model Number 3100A

Device Problems Break (1069); Device Maintenance Issue (1379)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

Start stop button did not work on a new preventive maintenance part.

• Brand Name: SENSORMEDICS 3100A
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION 207, INC. DBA CAREFUSION; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 4810676
• MDR Text Key: 5891819
• Report Number: 4810676
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2015
• Patient Sequence Number: 1