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

Model Number V60

Device Problems Smoking (1585); Sparking (2595); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported that the ventilator was due for battery replacement.When the ventilator was turned on the alternating current (ac) light emitting diode (led) was not flashing.The customer replaced the power management (pm) printed circuit board (pcb) then suddenly the biomed heard some clicking and saw sparks and smoke coming from the pm pcb.The ventilator was not in use on a patient at the time of the event occurred.

Manufacturer Narrative

Date of report: 16aug2018.Updated contact name.Date received by manufacturer: 26jun18.Mfr#2031642-2018-00942 is a duplicate of an event previously reported on mfr# 2031642-2018-00888.Any additional information will be submitted under the initially reported mfr #2031642-2018-00888.

Manufacturer Narrative

This was found to be a duplicate report that was submitted on 25apr2018, mfr#2031642-2018-00888.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: neisha markham ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7483650
• MDR Text Key: 107392186
• Report Number: 2031642-2018-00942
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2013
• 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