MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Electrical /Electronic Property Problem (1198); Sticking (1597); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

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

Event Type  malfunction  

Event Description

The manufacturer's field service engineer (fse) was dispatched to the site per customer request for the ventilator needs evaluation of the failure.The backup battery was depleted and did not have enough voltage to turn ventilator on and ventilator displayed ventilator inoperative with error code message of air valve stuck closed.Fse tried to turn the ventilator on in diagnostic mode and ventilator did not turn on it just reboots and alarms.The customer reported there was no patient involvement.

Manufacturer Narrative

This issue was reported in error.This case was created to perform an evaluation on the esprit ventilator that was involved in a patient death on (b)(6) 2014, refer to mdr 2031642-2014-00758.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6740399
• MDR Text Key: 81075203
• Report Number: 2031642-2017-02403
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2005
• 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