MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Alarm Not Visible (1022)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The customer reported that during testing of the ventilator, the battery low light will not work.He can completely take out the battery and the light will not light up.He also said that the oscillator overheat and oscillator stopped light will not light up either.No patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The 3100b ventilator was returned to factory service for evaluation.Per fa lab recommendation a carefusion factory service representative (fsr) performed the testing and evaluation per, test and servicing of 3100b ventilators.The factory service representative tested the battery, light and pressurized unit and the reported issue could not be duplicated.All reported information will be tracked and trended by carefusion.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 1100 bird center dr.; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 4689456
• MDR Text Key: 15968416
• Report Number: 2021710-2015-00737
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 773967-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2002
• 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