MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 01/28/2019.A follow-up report will be submitted once the investigation has been completed.

Event Description

It was reported that the ventilator was emitting an odor and generated a 24 volts failed error code.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.Event date not specified; estimate used.

Manufacturer Narrative

Date of report: 11feb2019.Date rec'd by mfr: 06feb2019.The customer has declined repair/service of the device at the moment.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8283437
• MDR Text Key: 134335473
• Report Number: 2031642-2019-00593
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1