MAUDE Adverse Event Report: CAREFUSION 203, INC LTV; VENTILATOR, CONTINUOUS

Model Number LTV 1150

Device Problems Circuit Failure (1089); Fire (1245); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

It was reported that the patient's ventilator was connected to an external marine battery with a cable.When the caregiver was disconnecting the cable from the ventilator pigtail, sparks and a three inch flame came from the ventilator at the strain relief connection to the ventilator.The ventilator continued to ventilate, however, the patient's mother powered the ventilator off and began to manually ventilate the patient.The patient was switched to another ventilator with no patient harm reported.Prior to this incident, fuses on the batteries continued to blow during ventilation and the batteries had been switched out three times to address this issue.

Manufacturer Narrative

The manufacturer was able to verify that the ventilator's pigtail had burned into two pieces near the strain relief.After a test pigtail was installed, the ventilator passed an extended test run using the customer¿s ventilator settings.During the ltv final test, the ventilator had a non-conformance with the peep pilot pressure test.This slight non-conformance would not result in a failure to ventilate properly.Internal inspection did not reveal any anomalies with the ventilator.The customer did not provide the external battery for further testing.The pigtail was replaced to correct the reported problem.

• Brand Name: LTV
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer (Section G): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: jennifer huybrecht ; 7633988395
• MDR Report Key: 4649826
• MDR Text Key: 17585029
• Report Number: 2031702-2015-00045
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-001
• Other Device ID Number: RMA 267005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2011
• 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 Age: 12 YR
• Patient Weight: 25