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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

The carefusion warranty claim form includes the incident description: oscillation failure.Alarm "oscillator stopped".

Manufacturer Narrative

(b)(4).The device was evaluated by the in-country distributor and has been returned to the mfr and not yet received at this time.According to the distributor, "pt circuit calibration test passed.Measure the power supply +15, -15v is normal.Measure the voltage across 9800uf capacitor is normal.Measure the resistance of the coil within the driver is normal.The indicator on driver controller module is red.Replaced the driver controller module the ventilator is o.K.".Carefusion issued a return goods authorization (rga) number for the return of the alleged driver power module assembly 3100a, part number 24-768930 on 11/24/2014.As of 12/23/2014 the alleged part number has not been received.Should the part be received and evaluated, a follow-up medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: christie rose ; 1100 bird center dr.; palm springs, CA 92262
• MDR Report Key: 4379591
• MDR Text Key: 20977240
• Report Number: 2021710-2014-00125
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 766522-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: NI/NA