MAUDE Adverse Event Report: CAREFUSION BIRD SENTRY BLENDER/ANALYZER/BIRD SENTRY LOW FLOW BLENDER/ANALYZER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number SENTRY BLENDER

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received will be evaluated and a follow up report submitted if required.(b)(4).The suspect device has not been received by carefusion.

Event Description

A customer reported to carefusion that a sentry blender did not alarm when the air or oxygen gas source was removed.The customer did not provide any additional information.It is unknown if the problem occurred while the unit was in use on a patient.

• Brand Name: BIRD SENTRY BLENDER/ANALYZER/BIRD SENTRY LOW FLOW BLENDER/ANALYZER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5374347
• MDR Text Key: 36514827
• Report Number: 2021710-2016-02705
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/11/2015

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: SENTRY BLENDER
• Device Catalogue Number: 16694A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1