MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that the unit has an error code message of air valve stuck closed.The customer reported there was no patient involvement.

Manufacturer Narrative

The reported problem was confirmed.The unit was not repaired and removed from service.No patient information provided by the customer.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred.There is a relationship of the device to the reported problem.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.

• 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: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6556438
• MDR Text Key: 74909635
• Report Number: 2031642-2017-01606
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

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: Health Professional
• 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: 04/19/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 04/19/2017
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2001
• 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