MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

The customer reported that the mean airway pressure was not stable while on a patient.The patient was removed from the oscillator and placed on another oscillator, no patient harm.

Manufacturer Narrative

(b)(4).The carefusion field service engineer evaluated the ventilator and found the mean airway pressure was reading lower than the flow analyzer and was fluctuating.Cleaned and reseated the connection to the pressure meter.Calibrated the airway pressure monitor transducer.Calibrated the pneumatics section after finding the bias flow was out of spec.Tightened loose nut and cross bolt on the min paw thumbwheel.Completed alarms checkout.Passed patient circuit calibration and vent performance check.No fluctuations and all readings within specifications.(b)(4).

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4862846
• MDR Text Key: 5808449
• Report Number: 2021710-2015-01144
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• 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: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2002
• 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