MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V680 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK

Model Number V680

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported that the ventilator generated a error which relevant to battery inoperable.The ventilator was not in use on a patient at the time of the event occurred.

Manufacturer Narrative

The v680 is an exported device and not available for commercial distribution in the united states.This is not reportable to fda and was submitted in error.(b)(6) 2018.

Manufacturer Narrative

On (b)(6) 2018.On (b)(6) 2018.The v680 is an exported device and not available for commercial distribution in the united states.This is not reportable to fda and was submitted in error.

• Brand Name: V680 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: neisha markham ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7559058
• MDR Text Key: 109768632
• Report Number: 2031642-2018-01122
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

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: Other
• Device Model Number: V680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 05/02/2018
• Supplement Dates FDA Received: 07/24/2018; 07/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2014
• 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