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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the alarm message: "check vent: blower temperature high" was displayed.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

During further investigation (fi), a visual inspection of the blower assembly outer surface revealed no evidence of damage or contamination.The blower assembly end cap was removed and a visual inspection of the impellers and surroundings did not reveal any signs of rubbing, damage, or contamination.Before applying power to the blower assembly the lm20 temperature sensor output was verified with a dc power supply set to 5.0 volts.It was found to be within specifications.The blower assembly was installed in an fi test ventilator which was booted into normal ventilation mode and delivered breaths.No errors were generated while operating in normal ventilation mode.The blower was allowed to run for approximately four (4) hours and no failures were generated.The fi test ventilator was booted into diagnostic mode.The ventilator was allowed to run approximately four (4) hours with unrestricted flow without overheating.The airflow accuracy test (pvt test 5) was performed and passed.

• 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): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7325881
• MDR Text Key: 101993304
• Report Number: 2031642-2018-00556
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• 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