MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. RESPIRONICS V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILIT

Model Number V60

Device Problems No Display/Image (1183); Moisture or Humidity Problem (2986)

Patient Problem No Information (3190)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

While trying to adjust settings, the user observed inconsistent device responses on the display screen.This was eventually determined to be the result of water penetration into the control panel, especially into the selection knob and "navigation ring" that is used to select a parameter and setting value.We have had at least four of our v60 ventilators fail for this problem, all within a period of six weeks.This report marks the fourth failure.
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manufacturer response for patient ventilator, respironics (per site reporter).
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manufacturer is aware of ventilator failures, and has supplied repair parts.Manufacturer has not been informed of this report.

• Brand Name: RESPIRONICS V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILIT
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos court; carlsbad, CA 92009
• MDR Report Key: 4833346
• MDR Text Key: 5907779
• Report Number: 4833346
• Device Sequence Number: 1
• Product Code: MNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1