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

Model Number 3100A

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

The following description of the event was copied from a carefusion ventilation complaint form submitted on behalf of user facility in (b)(6) by the distributor in (b)(6)."after being set up and pressurized, the oscillator will dump the pressure immediately or hold the pressure for anything up to 20 minutes.Regardless if it is kept pressurized, or oscillating, it eventually dumps all the pressure at once.".

Manufacturer Narrative

(b)(4).The foreign distributor determined that the most likely cause of the reported event was a faulty alarm board assembly.The foreign distributor was shipped a replacement alarm board assembly to repair the device and return it to service.Carefusion issued a return goods authorization (rga) number to the foreign distributor for the return of the alleged faulty alarm board assembly for evaluation.As of (b)(4) 2014 the alleged faulty alarm board assembly has not been received.Should the alleged faulty alarm board assembly be received and evaluated, a follow-up medwatch report will be submitted.

Manufacturer Narrative

Failure analysis: 3100a alarm board assy pn: 768588, sn: (b)(4) was received and routed to the carefusion failure analysis lab for evaluation.The carefusion failure analysis lab technician evaluated the alarm board assy and found that along with a corresponding audible alarm, the hi paw led and min paw led were coming on intermittently.It was found that the output voltage at comparator ic u5 pin 1 and pin 14 were going low with no alarm condition causes the ventilator to dump its patient circuit pressure and shut down.The failure analysis lab technician replaced u5 and now the ventilator is functioning normally.Finding/root-cause: duplicated, unit dumps the patient circuit pressure, complaint allegation.Defective ic u5, ic-339 v comparator low power pn: 861648.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60081 ; 8473628056
• MDR Report Key: 4390560
• MDR Text Key: 5308682
• Report Number: 2021710-2014-00149
• 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,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• 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: 768909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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