MAUDE Adverse Event Report: CAREFUSION/VIASYS; HFOV

Model Number 3100B

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 02/07/2014

Event Type  Death  

Event Description

A (b)(6) pt in septic shock, severe ards v pna, h1n1 pos and w/ strep pna.On a high-frequency oscillating ventilator with no and vasopressors.Vent began to alarm at approx 18:05 with variable mean airway pressure readings.Resp therapist called in and felt that a piece of the oscillator needed replacing and removed the pt from the vent.Pt hr and sats were in the 70's at the time.Pt was bagged w/ 100% oxygen (in error), and physician quickly switched to bagging with no.Code blue interventions began, but they were unable to resuscitate pt in order to place back on a replacement oscillator.Clinical engineering's initial findings: clinical engineering inspected the device and was able to duplicate the user complaint of mean airway pressure (map) not holding.Upon further testing, it was determined that the ventilator was working to mfr specifications.The map high limit alarm was set to 46cmh2o.As per the normal operation of this ventilator, once the map exceeds the high limit set by the user, an audible and visual alarm will occur, and the ventilator will depressurize.Once the map falls to a level of 12 +/- 3cmh2o below the set max map setting, the limit valve will allow re-pressurization to its normal operational state.Should the high map condition persist, the alarm will repeat until the condition is resolved.Because this type of ventilator is very different than most of rt's fleet, it requires specific user operational and troubleshooting training.In this case, our testing to date shows that a properly working ventilator was disconnected from the pt because the user(s) though the ventilator was malfunctioning, even though it apparently was working as designed.The ventilator was tested for 6 hrs with no problems noted.Upon further investigation, the following is a clinical engineering addendum to the previously issued, and preliminary, f/u report: on (b)(6) 2014, vendor rep completed testing and checkout of the ventilator and no problems were found.Not all disposables involved in the incident were sequestered.The "caps" tested were the ones included with the tubing when clinical engineer rec'd the vent.Apparently, these were the 3rd set of caps installed by rt on this vent.Changing caps had not helped the problem.Clinical engineer did not receive the other caps.Apparently, when clinical engineer rec'd the vent, the settings were not the settings used for this pt but were some settings placed by rt to test the vent after disconnecting it from the pt.Clinical engineer did not have the pt settings at the time of our initial testing.Subsequent testing, at the now-documented pt settings, did not reveal any ventilator problems.Root cause: unk.All of the equipment provided to clinical engineer tested within mfr specifications; therefore, the root cause of the inability of the vent to hold pressure was, most likely, not caused by any of the equipment or disposables provided to clinical engineer for testing.

• Type of Device: HFOV
• Manufacturer (Section D): CAREFUSION/VIASYS; 22705 savi ranch pkwy; york linda CA 92687
• MDR Report Key: 3833520
• MDR Text Key: 4402491
• Report Number: 3833520
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3100B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2014
• Distributor Facility Aware Date: 02/07/2014
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 17 YR