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

Model Number 3100A - UPGRADE

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch 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.The carefusion fse went onsite and found no gas flowing from the pr5 cooling gas regulator.Lack of cooling gas caused repeated driver overheating.Due to potential damage to driver he the replaced driver and installed 6k pm kit which includes the pr5 regulator.I performed 6k pm, patient circuit calibration @ 40 cmh2o, and performance test @ 20.1 cmh2o paw / 64 cmh2o amplitude.As of this date the part has not been received for evaluation.When it has been received and evaluated a supplement will be filed.

Event Description

The following description of the event was documented by a carefusion tech support specialist in a response to a phone conversation with a user facility representative on (b)(6) 2014.The customer called to report that this unit is intermittently starting and stopping on its own.The unit seems to pressurize fine, the performance check seems to come in fine, but now the oscillator will stop on its own and alarms.The amps drop to zero and the map seems to stay stable.Then the unit will start up again on its own without her depressing the start/stop button.The hz drops from 15 to 11 hz as well.

• 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: marshall thompson ; 7607787307
• MDR Report Key: 5415626
• MDR Text Key: 38228326
• Report Number: 2021710-2016-02942
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A - UPGRADE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/1997
• Type of Device Usage: Reuse
• Patient Sequence Number: 1