MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/16/2019.

Event Description

The customer reported a dim display.It is unknown if the ventilator was being used on a patient at the time of the reported event., however, there was no patient harm reported.

Manufacturer Narrative

Date received by manufacturer: 08nov2019.Date of report: 11nov2019.The customer did not respond to multiple requests to confirm patient involvement.The fse (field service engineer) evaluated the ventilator and reported that the battery is past due for replacement with no parts available to complete the repairs needed.No service was rendered.The unit is out of service.Determination could not be made that the device failed to meet specifications.It is unknown if the device was being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts were returned for failure investigation.Therefore, the root cause at the component level could not be determined.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9199031
• MDR Text Key: 187605408
• Report Number: 2031642-2019-10128
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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: No Information
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1