MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATORY VENTILATOR

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  Injury  

Event Description

The customer reported that while in patient use there were issues with mean airway pressure (map).He said that the map was set to around 13.5 cm.He noticed the map drop to around 8.9 cm so he then looked for any leaks with the circuit and couldn't see anything.He said that he went up on the bias flow to keep the map at 13.5 cm.He said he had to go up on the bias flow because the map kept dropping.The settings were map 13.5 cm, amplitude 26 cm, hz 10.0, bias flow at 20 lpm, it.33, fio2 55%.He ended up with a bias flow as high as 35 lpm to maintain the map at 13.5 cm.The patient was removed from the ventilator and placed on another 3100a unit.No patient compromise noted.

Manufacturer Narrative

(b)(4).Carefusion technical support arranged for replacement of the ventilator for another unit through third party service.

Manufacturer Narrative

This supplemental report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.

Manufacturer Narrative

The carefusion failure analysis engineer examined the 3100a ventilator and found that an installed known good patient circuit could not be calibrated.Found that the blue limit pressure reading was 6.7cm h2o.Per 3100a hfov test procedure (b)(4) this pressure should be from 0.55 to 0.75 psi or 38.71 to 52.78 cmh2o.Calibrated this value to 45.75 cm h2o by adjusting pr2 and now the patient circuit can be calibrated.Duplicated the customer complaint allegation.Return ventilator to the service department with recommendation to replace any materials as required, rework to current configuration, recalibrate, retest per specifications and then return to customer.

• Brand Name: HIGH FREQUENCY OSCILLATORY VENTILATOR
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 4808083
• MDR Text Key: 5829205
• Report Number: 2021710-2015-01054
• 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: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/29/2015; 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2001
• 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