MAUDE Adverse Event Report: CAREFUSION CAREFUSION

Model Number 3100B

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion failure analysis engineer examined the 3100b and found that the bias flow could not be adjusted to 30 lpm and therefore could not be set to the ventilator performance checks settings.Determined the pr7 was out of calibration.Calibrated pr7 to a maximum bias flow reading of 60+/-1 lpm per test and servicing of 3100b procedure.Noted that the pr7 regulator made a squeaking sound as it was being adjusted.Operated unit at ventilator performance checks settings for 4 hours with no problems.Finding/root-cause: could not duplicate, the bias flow was fluctuating, complaint allegation.

Event Description

The customer reported that while in pt use the bias flow meter was fluctuating so much that they decided to take the unit off the pt and replace it with another 3100b of their own.

• 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: 5014920
• MDR Text Key: 23946059
• Report Number: 2021710-2015-01418
• 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
• Report Date: 07/23/2015

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 773967-RNT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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
• Patient Outcome(s): Required Intervention