MAUDE Adverse Event Report: RESIRONICS CALIFORNIA INC ESPRIT VENTILATOR; VENTILATOR, CONTINOUS, PRODUCT CODE: CBK

Model Number V1000

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported the ventilator exhalation valve became stuck during normal ventilation operation.The customer reported there was no patient harm.Completion of service is pending.

Event Description

The manufacturers field service engineer was unable to duplicate exhalation valve stuck.Review of the diagnostic log could not confirm the exhalation valve stuck.No parts replaced.Device passed all applicable testing.

Manufacturer Narrative

Device evaluation and service pending.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR, CONTINOUS, PRODUCT CODE: CBK
• Manufacturer (Section D): RESIRONICS CALIFORNIA INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: dennis daniels ; 2271 cosmos court; carlsbad, CA 92011 ; 7609180169
• MDR Report Key: 3870206
• MDR Text Key: 4566502
• Report Number: 2031642-2014-00479
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

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: Respiratory Therapist
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2007
• 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