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

Model Number 3100A

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

Patient Problem No Information (3190)

Event Type  malfunction  

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).Cap/diaphragm (p/n 766896) lot 0000509596, lot 0000535473, and lot 0000482040), were not returned for evaluation.Based on the reported event, cap/diaphragm (p/n 766896) is a known issued and has been addressed by an internal action.

Event Description

The customer reports finding cap diaphragms 766896 that are "broken" while in the package or fall apart during use.She explains that they inspected stock and found three cap diaphragm sets that were "broken" inside the package.(when she says "broken," she means that the "luer with balloon has separated from the top white cap part." the caps that have failed while on a patient, initially passed the patient circuit calibration.While on a patient, they just "fell apart." the two that failed while on patients were thrown away.She only has the three sets that were found "broken" inside the package.Carefusion technical services issued replacement product.

• 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 ; 7149227830
• MDR Report Key: 5415331
• MDR Text Key: 38219289
• Report Number: 2021710-2016-02923
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• 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
• Report Date: 07/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2013
• 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