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 06/05/2015

Event Type  malfunction  

Event Description

The customer reported that while in patient use the map pressure is fluctuating and not holding the map of 13, the reading is jumping from 10 to 17.The patient was removed from the oscillator placed on another oscillator, no patient harm.

Manufacturer Narrative

(b)(4).Evaluation by carefusion is anticipated but has not yet begun.

Manufacturer Narrative

The carefusion failure analysis engineer examined the ventilator and found no problems.Operated unit at standard settings for one hour and noted that the map pressure stayed at the set 20 cmh2o.Adjusted the map to 13 cmh2o and further noted that the map pressure stayed at this set pressure.Affected patient circuit was not returned with the 3100a rental unit.Could not duplicate complaint allegation.Finding/root cause: could not duplicate map pressure is fluctuating complaint allegation.Found that the piston control knob is broken off and is missing.Vent sent to factory service department for replacement of materials as required, reword to current configuration, recalibrate, retest per specifications and then return to customer.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: 4877728
• MDR Text Key: 22066240
• Report Number: 2021710-2015-01154
• 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,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

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-RNT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/1997
• 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