MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/23/2013

Event Type  Injury  

Manufacturer Narrative

This initial 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.(b)(4).The device/components documented as returned, failure analysis evaluation is not available.

Event Description

The customer reported the c30 on the unit was burnt and requested a new alarm board.The unit seems to run fine and alarms correctly but he needs a replacement because it's damaged now.The unit was running on a patient and they smelled something electrical burning.He states they swapped the unit out with another 3100a and there was no patient compromise.A replacement alarm board was issued and a return issued to sent defective alarm board for evaluation.

Manufacturer Narrative

Failure analysis (fa) lab received an alarm board assy (3100a).Performed alarm function checkout.The fa lab performed an investigation and the system worked as normal for 2 hours and no problems were found.The fa lab was able to duplicate the reported issue of c30 was burned on alarm board.

Manufacturer Narrative

(b)(4).

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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 ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5418216
• MDR Text Key: 38249709
• Report Number: 2021710-2016-02984
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2013

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2013
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2016; 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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