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

Model Number V60

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Loss of Power (1475); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the ventilator shut down and alarmed while in use in normal ventilation operation.The customer reported the unit was in use on a patient and there was no patient harm.The customer reported the unit had an odor of overheating when it shut down, and the unit would then not turn back on.As the device is out of warranty, the facility biomedical engineer contacted manufacturer's product support (pse) for assistance.Pse advised the biomedical engineer evaluate the power supply and power management pcb board for the reported problem.The biomedical engineer reported the power management pcb board was replaced and the reported problem resolved.The biomedical engineer reported the power management board removed from the unit was no longer available.

Manufacturer Narrative

Device out of warranty; no request for manufacturer's service.

• 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: 3790523
• MDR Text Key: 4440685
• Report Number: 2031642-2014-00312
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/09/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2010
• 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