MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, CONTINUOUS, FACILITY USE/CBK

Model Number BLENDER

Device Problem Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Biomed at a user facility reported a blender with "a couple of buttons on the touchscreen that are not responding." no pt involvement.

Manufacturer Narrative

(b)(4).Carefusion technician support provided the biomed with the p/n key pad control for the unit.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE/CBK
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFISOPM; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 9483729-57
• MDR Report Key: 4788182
• MDR Text Key: 5853476
• Report Number: 2021710-2015-01002
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLENDER
• Device Catalogue Number: 15625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1