MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number 3100A

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion field service engineer evaluated the ventilator and found ddi out of calibration with a shift to the right of center.A 2k pm due.Calibrate per 2k pm procedure and verified performance.Ventilator passed all performance checks.

Event Description

The customer reported that the ventilator has ddi drift with settings: map 9, amplitude 29, bias flow 15.No pt involvement.

• Brand Name: CAREFUSION
• Manufacturer (Section D): CAREFUSION ; yorba linda CA
• Manufacturer (Section G): CAREFUSION ; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway dr. ; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5014943
• MDR Text Key: 23960068
• Report Number: 2021710-2015-01419
• 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: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2000
• 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