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

Model Number 3100B

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 08/05/2013

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).

Event Description

Complaint form received via (b)(4) tech support on behalf distributor in the (b)(4) details an event which occurred at a user facility: event details the third party distributor in the (b)(4), reported "a problem with part number 11744-850k batch number (b)(4), it appears that it is not a complete set and that certain parts are not molded on as they should be." the end user is [redacted].It was afterwards revealed that the alleged problem was discovered by the sales manager [redacted] when she went to do some training at the hospital on the (b)(6).It was also reported by [redacted]: "because they (the hospital staff) have not had any training & are not experienced with oscillation they did not know to look for leaks in the system when the oscillator does not achieve pressures of 39-42 during set up & calibration.Once i had found the set i was using to be faulty i looked at the rest of their stock & found the tubing to be loose in the packet instead of attached where it should be." it was also reported by sales manager, that the faulty product from batch (b)(4) "was not used on a patient - however in the last few weeks they (the hospital staff) have sent all of their machines to [redacted] with the same problem (not reaching pressure) - [redacted] have been unable to find faults with the machines so it may be that some have been used on patients whilst faulty." the hospital will return the faulty products and sales manager has planned to send replacements.

• 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: 5415339
• MDR Text Key: 38228213
• Report Number: 2021710-2016-02933
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/06/2013

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: 3100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1