MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number 3100B

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The customer reported that the amplitude is low on the performance check.The pt calibration came out ok.He checked the pneumatics and found that he could not adjust the bias flow meter to 60.No pt involvement.

Manufacturer Narrative

(b)(4).The carefusion failure analysis tech will evaluate the alleged failed part if it is returned to the manufacturer.

• Brand Name: CAREFUSION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: wendy schumacher ; 7607787219
• MDR Report Key: 4749063
• MDR Text Key: 5821646
• Report Number: 2021710-2015-00894
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2015

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: 3100B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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