MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

Customer reported the unit failed est.No patient/user harm reported.

Manufacturer Narrative

Event date: (b)(6) 2018.07/aug/2018.30/jul/2018.The replaced solenoid was returned for evaluation.No signs of damage or contamination were found.During testing there was a heavy leak detected and the block patient wye test failure was confirmed.This failure was traced to the single station solenoid which was not attached to the manifold assembly correctly.It was found that the connection between the solenoid and manifold was loose.Repair was made and part passed additional testing.The determination could not be made that the device initially failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Tightening the solenoid to the manifold corrected the failure with this single station solenoid.

Event Description

Field service engineer heard a hissing sound from the back left of the unit.The extended self test failed the oxygen delivery test.The solenoid 1 assembly was replaced and returned.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: neisha markham ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7554902
• MDR Text Key: 109656506
• Report Number: 2031642-2018-01115
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: Other
• Device Model Number: V1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2006
• 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