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

Model Number V60

Device Problems No Display/Image (1183); Device Emits Odor (1425); Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

The customer reported the ventilator display went blank and had an odor of overheating.Ther customer reported the ventilator was in use on a patient and there was no patient harm.The manufacturers field service engineer (fse) was able to duplicate the reported problem of overheating smell.During evaluation, the fse reported the odor was coming from the motor controller pcb board.The fse reported the motor controller pcb board and power management pcb board were replaced to address the reported problem.Applicable final testing was performed per operating specifications and passed.

Event Description

Factory analysis of the returned motor controller pcb board revealed a capacitor short, which resulted in the reported odor.There were no failures identified on the returned power management pcb board.

Manufacturer Narrative

Supplemental report.

• 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: 4009837
• MDR Text Key: 4780299
• Report Number: 2031642-2014-00843
• 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,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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