MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the battery led is flashing and beeping; backup battery is not holding a charge.The customer reported there was no patient involvement.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: nancy ataide ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 5903099
• MDR Text Key: 53350537
• Report Number: 2031642-2016-02141
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2003
• 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