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

Model Number 3100B

Device Problem Increase in Pressure (1491)

Patient Problem Death (1802)

Event Date 02/10/2014

Event Type  Death  

Event Description

The following description of the event was copied from an e-mail from a carefusion clinical education specialist."i was scheduled to teach there for a day; 3100b in the morning, 3100a in the afternoon, 1 hour sessions.[name removed], clinical educator called me and asked me to come in early to help staff with some troubleshooting.He actually took me to the 3100b above and asked me what could cause a high pressure alarm to sound.Both he and the biomed tech were there, along with [name removed], salesman.They both were very confident that the issue was operator error and not the vent.A (b)(6) year old female passed away while on the vent.The rt was inexperienced with the oscillator.I told them what could cause the high pressure alarm to go off, but did not say what happened to this patient as i was not there.I am not sure if they have called this in or not, as they believe it was not the vent." the following description of the event was documented by a carefusion tech support specialist in response to a phone conversation with a user facility representative(s)."[name removed] called to request a service call.He explains that this vent was involved in a patient incident, but they don't think there is anything wrong with the vent.The hospital would like carefusion to perform a "performance verification".".

Manufacturer Narrative

The user facility did not submit a user facility report to the manufacturer.Event codes were derived based on information documented by a carefusion tech support specialist in response to a phone conversation(s) with a user facility representative and information provided by the carefusion clinical education specialist.(b)(4).Carefusion has made multiple requests via e-mail to the user facility seeking additional information concerning the reported event including the primary and secondary causes of death of the patient and a determination if the device caused or contributed to the death.As of (b)(4) 2014, there has been no response from the user facility.The following information concerning the evaluation of the device is a summary of the information documented by the carefusion field service representative.The carefusion field service representative evaluated the device and was not able to reproduce the reported failure thus was not able to identify a root cause in this alleged event.In addition, the carefusion field service representative performed a ventilator performance checks as requested by the user facility and found that the device was within specified ranges.Upon completion the device was released back to the customer ready to be placed back into service.Should additional information became available a follow-up medwatch report will be submitted.

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 3690721
• MDR Text Key: 4244529
• Report Number: 2021710-2014-00009
• 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: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/10/2014

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
• Device Catalogue Number: 770155
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2014
• Device Age: 12 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2002
• 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): Death