MAUDE Adverse Event Report: CAREFUSION SENSORMEDICS; VENITILATOR, HIGH FREQUENCY / LSZ

Model Number 3100A

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

The following description of the event was copied from a warranty claim form submitted by the foreign distributor."oscillator tma 31715 at gsh has no audible alarm except for power failure.This fault was discovered during a2000hr calibration.Was product on pt? no.

Manufacturer Narrative

The foreign distributor did not submit a user facility/importer report to the mfr.Event codes were derived based on info provided by the foreign distributor.(b)(4).The foreign distributor evaluated the device and determined that the cause of the reported event was associated with the alarm board assembly.The foreign distributor repaired the device by replacing the alarm board assembly with one from their stock.Carefusion issued a return goods authorization (rga) number to the foreign distributor for the return of the alleged faulty alarm board assembly for eval.As of september 18, 2014 the alleged faulty alarm board assembly has not been received.Should the alarm board assembly return for eval, a f/u medwatch report will be submitted once the eval is complete.

• Brand Name: SENSORMEDICS
• Type of Device: VENITILATOR, HIGH FREQUENCY / LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: antonio cervera ; 1100 bird center dr.; palm springs, CA 92262 ; 7607787307
• MDR Report Key: 4209370
• MDR Text Key: 5148179
• Report Number: 2021710-2014-00053
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Device Catalogue Number: 768909
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2004
• 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