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

Model Number V60

Device Problems Break (1069); Leak/Splash (1354); Failure to Power Up (1476); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The international customer reported that liquid run into the device and would not turn on.The device was not in use on a patient therefore there was no patient involvement or harm.The service technician evaluate the device and found liquid on the boards.The power supply and the motor controller board were replaced to address the reported problem.Failure analysis on the returned motor controller board revealed cap c15 on the mc board is leaking electrolyte, which caused multiple components to short out.The 12 volt signal was shorted to ground at the j6 connector on the mc board due to the leak.A failure of the device motor controller pcb board may result in non-operation of the blower which may affect ventilation in normal ventilation mode use.

• 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: 4225243
• MDR Text Key: 16450802
• Report Number: 2031642-2014-01346
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• 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: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2010
• 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