MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; ESPRIT/V200 VENTILATOR WITH APRV OPTION

Model Number ESPRIT VENTILATOR V1000

Device Problem Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.

Event Description

It was reported that the ventilator's display was not working, had a white display.There was no patient involvement.The service engineer (se) inspected the device, removed and reconnected the video graphic array cable, and the issue was addressed.The unit was checked overall, cleaned, functionally tested, and no abnormality was confirmed.

• Brand Name: RESPIRONICS
• Type of Device: ESPRIT/V200 VENTILATOR WITH APRV OPTION
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11611861
• MDR Text Key: 244205225
• Report Number: 2031642-2021-03250
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K10083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial

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: ESPRIT VENTILATOR V1000
• Device Catalogue Number: 701-01000-00
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2021
• Date Device Manufactured: 10/26/2010
• 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