MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13jul2020.

Event Description

The customer reported that the device had touchscreen failure.The device was in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4: 14sep2020.B4: 14sep2020.The device was not on a patient at the time of the event.There was no patient or user harm reported.An authorized service personnel(asp) was dispatched to the customer site, and it was determined that the video graphic array(vga) printed circuit board assembly(pcba) needed to be replaced to return the device to working condition.The customer used another service provider to perform the corrective maintenance, and the vga-pcba was replaced.The device passed all performance verification testing.Following the repair, the device was returned to the customer to be placed back into service.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: 10268014
• MDR Text Key: 199698438
• Report Number: 2031642-2020-02332
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.