MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. ESPRIT VENTILATOR; VENTILATOR, CONTINUOUS

Model Number V1000

Device Problems Loss of Power (1475); Sticking (1597); Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

The customer reported the device alarmed and shut down while in use.The customer reported no patient harm.Upon evaluation the manufacturers field service engineer (fse) reported the device would not power on.The fse replaced the power supply to correct the reported problem.Review of the diagnostic log shows an oxygen valve stuck closed error followed by a power fail occurrence.Per engineering review the oxygen valve stuck closed is likely due to the power supply failure.The device passed performance verification testing.

Event Description

Factory analysis of the returned power supply revealed a capacitor failure that resulted in the reported power issue.

Manufacturer Narrative

Supplemental report.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer Contact: dennis daniels ; 2271 cosmos. ct.; carlsbad 92011 ; 7609187300
• MDR Report Key: 4224154
• MDR Text Key: 5001052
• Report Number: 2031642-2014-01345
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

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: Health Professional
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2007
• 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