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

Model Number 3100A

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion technical support specialist in response to a phone conversation with a user facility representative(s)."[name removed] called requesting a service call for this vent.Complaint: when unit first turns on, the alarm silence activates automatically as usual, but after 45 seconds, the alarm silence button remains engaged.The unit doesn't alarm.".

Manufacturer Narrative

The user facility did not submit a user facility report to the manufacturer.Events codes were derived based on information documented by a carefusion technical support specialist in response to a phone conversation(s) with a user facility representative.(b)(4).The following information concerning the evaluation of the device is a summary of the information documented by the carefusion field service representative.The carefusion field service representative evaluated the device and was not able to reproduce the reported failure thus was not able to identify a root cause in the alleged event.The carefusion field service representative ensured that all alarm pcba connections were fully seated and ran the device through a complete checkout per the operator's and service manuals to ensure the device was operating as intended.Upon completion the device was returned to the customer to be placed back into service.As the reported event could not be reproduced, carefusion considers this to be an isolated incident.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 3944279
• MDR Text Key: 4537829
• Report Number: 2021710-2014-00022
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/09/2014
• Device Age: 12 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2002
• 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