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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); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

It was reported that the ventilator generated an error code for the blower temperature high. No patient harm reported.

 
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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)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
neisha markham
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7555218
MDR Text Key109664645
Report Number2031642-2018-01117
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2014
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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