MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR; VENTILATOR, CONTINUOUS

Model Number V60

Device Problems Display or Visual Feedback Problem (1184); Volume Accuracy Problem (1675); Delivery System Failure (2905)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The international customer reported the tidal volume displayed on the ventilator was not accurate.The customer reported the set volume was 500 ml and the reading was 200-300 ml.The customer reported the issue occurred after the device had been serviced.The customer reported the device was not in use on a patient therefore there was no patient involvement or harm.The service technician confirmed the reported problem.The service engineer replaced the gas delivery system to address the reported problem.

Manufacturer Narrative

Gas delivery system.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer Contact: dennis daniels ; 2271 cosmos ct.; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 3825460
• MDR Text Key: 4395589
• Report Number: 2031642-2014-00370
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/23/2014

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: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2012
• 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