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: 26jun2020.

Event Description

It was reported that the unit had a touchscreen failure.It is unknown if the device was in use at the time of the event; however, there was no patient harm reported.

Manufacturer Narrative

G4: 30jul2020 b4: (b)(6) 2020 it was reported to philips during the repair of the device for a damaged case, the philips field service engineer (fse) noted that the touchscreen was not functional.The device was not being used on a patient at the time of the event.The touchscreen failure was noted by the fse during servicing of this device.The touchscreen failure was noted by the fse during servicing of this device.The replacement part information was requested on (b)(6) 2020 for repair of the touchscreen.The fse was unable to order the replacement parts as the esprit ventilator has reached end of life and the replacement parts are no longer available.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: 10203519
• MDR Text Key: 196937991
• Report Number: 2031642-2020-02201
• 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: 06/09/2020

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: 06/09/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1