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

Model Number 3100A

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

Should any additional information be received by the customer then an additional report will be submitted.(b)(4).At this time carefusion is waiting for components from customer for evaluation.

Event Description

The customer reported that this 3100a high frequency oscillating ventilator (hfov) "stopped" while on a patient and would not re-pressurize.Alternate ventilation was provided via manual hand-bag-ventilation and the unit was replaced with a known good hfov.The customer stated that there was no patient injury or harm associated with the reported event.

Manufacturer Narrative

The carefusion failure analysis lab received the suspect driver power module assembly from the involved 3100a high frequency oscillating ventilator.The reported issue was duplicated and the malfunction was found to be due to pins 1 and 4 being short at the connector p2 of the power width modulator amplifier.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5602519
• MDR Text Key: 43437244
• Report Number: 2021710-2016-03622
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Weight: 1