MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Failure to Cycle (1142)

Patient Problem No Information (3190)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion tech support specialist in response to a phone conversation with a user facility rep on (b)(4) 2014."[name removed] called the after hours phone to get some help with a rental unit that had shut off while on a pt.[name removed] reports the unit lost all power, all leds and panel meters went blank, they did hear an alarm for a few seconds then it shut off as well.They plugged the unit into several other ac outlets and could not get the unit to turn on.Advised it sounded like an issue with the power supply and that it had to be replaced.She understood and they were going to put the pt on a 3100a.Unk what other setting pt was on.No pt harm noted at that point".On (b)(4) 2014 the 3rd party service company picked up the device from the user facility for evaluation.During the evaluation the 3rd party service company was not able to power up the device and opted to send the device to carefusion for evaluation.The following description of the event was copied from a maude event reported received by carefusion from the fda on (b)(4) 2014."pt on a carefusion 3100b vent when the ventilator stopped working.Pt on a cardiac monitor, iv with iv medications - these continued.".

Manufacturer Narrative

The user facility did not submit a user facility report to the mfr.Event codes were derived based on info provided by the user facility via phone conversation(s) and info contained on the maude event report received from the fda.(b)(4).The following info concerning the evaluation of the device is a summary of the info documented by the carefusion factory service rep.As evaluation of 3100b serial number (b)(4) was conducted by the carefusion service dept to assess the reproductibility of the reported event.The initial inspection reveled that the 3100b's o2 green breathing gas hose was connected to the blender's o2 oxygen primary inlet port instead of the blender's primary outlet port, this caused the 3100b not to pressurize.After connecting the 3100b's o2 green breathing gas hose to the blender's primary outlet port the 3100b was able to pressurize.It was also noticed that the pr7 regulator was set above the required 60 l/min.The pr7 regulator was adjusted down to 60 l/min as stated in the 3100b high frequency oscillatory ventilator service manual.Carefusion was not able to determine how or when the above set and calibration errors occurred.The 3100b oscillator was ran for 96 hrs without exhibiting any issues associated with the reported event, the 3100b oscillator met factory specs.As a precaution to the alleged event, the power cable assembly p/n 770129-102 which includes the rfi filter assembly will be replaced prior to returning the 3100b oscillator to the rental pool.

Manufacturer Narrative

This supplemental 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.The (b)(6) 2014 should have been entered in this field.The information for this follow-up report was noted on 10/12/2015.This was initial reported as unk.The carefusion received a maude report from the fda that indicated that the user facility had submitted a report therefore, this should have been checked "yes".Information redacted from initial mdr, submitted in error.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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 ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 4224520
• MDR Text Key: 4969872
• Report Number: 2021710-2014-00062
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 773967-RNT
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2014
• Distributor Facility Aware Date: 06/01/2014
• Device Age: 12 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2002
• 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
• Patient Outcome(s): Required Intervention