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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 Problem Improper Device Output (2953)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The touch screen was replaced to address the finding.
 
Event Description
The international customer sent the device to the international service center for routine periodic maintenance.The service technician during service identified that the lower part of screen did not respond well.There was no patient involvement.
 
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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
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key6186242
MDR Text Key63186263
Report Number2031642-2016-03503
Device Sequence Number1
Product Code MNT
UDI-Device Identifier0088483802006
UDI-Public(01)0088483802006
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082660
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 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberV60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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