MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2018.Date of report: 27sep2018.Valid phone number not provided.Philips fse (field service engineer) could not duplicate or confirm the reported issue.Checked external battery after charging.The battery was tested and passed required tests.After charging the battery the unit is back to full functionality.

Event Description

The customer reported an auto shut off.There was no patient or user harm reported.The event date was not specified; estimate used.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: lisa cardenas ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7916646
• MDR Text Key: 122004756
• Report Number: 2031642-2018-01986
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2018

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: 09/03/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2010
• 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