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

Model Number V60

Device Problems Overheating of Device (1437); Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

The manufacturers service technician reported the sensor ribbon cable was damaged due to indications of overheating.The service technician replaced the air & o2 flow sensor assembly to address the reported problem.Applicable final testing was performed per operating specifications.

Manufacturer Narrative

Supplemental report.Flow sensor assembly.

Event Description

The international customer reported that the ventilator stopped working and displayed machine and proximal pressure sensors failure on start up.The customer reported the ventilator was in use on a patient and there was no patient harm.Occurrence of a pressure sensors failure during use in normal ventilation operation may affect the accuracy of the system pressure measurement and may result in the unit going vent inop.A vent inop condition during operation will result in a visual and audible alarm and precludes continued safe operation of the ventilator.The user must provide alternative ventilation and have the ventilator serviced.The customer reported the ventilator had an odor of overheating.Evaluation and service of the ventilator are in progress.

Manufacturer Narrative

Evaluation & service in progress.

• 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: 4037316
• MDR Text Key: 4837090
• Report Number: 2031642-2014-00905
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K082660
• 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,Followup
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• 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?: No
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2009
• 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