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U.S. Department of Health and Human Services

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

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problems Blower (738); 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.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, 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 Key7325881
MDR Text Key101993304
Report Number2031642-2018-00556
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082660
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberV60
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/25/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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