MAUDE Adverse Event Report: CAREFUSION, INC P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the device from the customer.In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.

Event Description

The customer stated that while testing the unit it was found that the device does not have an audible alarm when it should.There was no patient involvement at the time of the incident.

Manufacturer Narrative

Results of investigation: the factory service department received the blender for evaluation and found a damaged alarm reed plate.The reed plate was routed to the failure analysis lab however due to the damage an investigation was unable to be performed.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5626483
• MDR Text Key: 44730824
• Report Number: 2021710-2016-03668
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 10041A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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