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

Model Number 3100B

Device Problems No Audible Alarm (1019); Failure to Cycle (1142)

Patient Problem Death (1802)

Event Date 07/08/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The carefusion failure analysis technician will evaluate the alleged failed product if it is returned to the manufacturer.

Event Description

The customer reported that while in patient use the ventilator suddenly shut down.Confirmed by the doctor on duty, who was in the room next to the patient bed that he did not hear any sound alarm signal, though the alarm signal used to be very loud, especially during night time.The nurse on duty confirmed no sound alarm signal generated when the piston stopped.The patient was placed on conventional cmv and later died due to sepsis.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION ; yorba linda CA
• Manufacturer (Section G): CAREFUSION ; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5001657
• MDR Text Key: 22960543
• Report Number: 2021710-2015-01380
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• 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: 771453-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: MOTOR PHILLIP: MEASURE SPO2
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 52