MAUDE Adverse Event Report: CAREFYSUIB BIRD; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The following description of the event was copied from a carefusion ventilation complaint form submitted on behalf of the foreign user facility by the foreign distributor."test was performed on all equipment in (b)(6) and they discovered that on 5 bird blenders, alarm cap doesn't perform as it should, no alarm sound was heard.".

Manufacturer Narrative

(b)(4).The foreign user facility determined that the most likely cause of the reported event was a malfunctioning alarm cap assembly.Carefusion is in the process coordinating with the foreign user facility via the foreign distributor for the return of the alleged faulty alarm cap assembly for evaluation.Should the alleged faulty alarm cap assembly be received and evaluated, a follow-up medwatch report will be submitted.

• Brand Name: BIRD
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFYSUIB; yorbia linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: james stytle ; 7608837120
• MDR Report Key: 4458800
• MDR Text Key: 5185346
• Report Number: 2021710-2015-00109
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 11321A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/11/2014
• Device Age: 10 MO
• Event Location: Other
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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