MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS ESPIRIT VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V1000

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  Injury  

Event Description

A patient was intubated and on a ventilator.The ventilator alarm started sounding and external battery light flashing.Respiratory therapy contacted and attempted to changed outlets and cords.The status of the equipment did not change.The ventilator powered down prior to being exchanged.Respiratory therapy was able to exchange the ventilator immediately after.

• Brand Name: RESPIRONICS ESPIRIT VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC
• MDR Report Key: 8396316
• MDR Text Key: 138157581
• Report Number: MW5084692
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V1000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention