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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 Intermittent Continuity (1121)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 24june2019.A follow-up report will be submitted once the investigation has been complete.
 
Event Description
The customer reported main light emitting diode (led) turns green intermittently.Led will flicker green to amber while operating.There was no patient or user harm reported.
 
Event Description
The customer reported main light emitting diode (led) turns green intermittently.Led will flicker green to amber while operating.There was no patient or user harm reported.
 
Manufacturer Narrative
Date rec'd by mfr: 07oct2019.Date of report: 07oct2019.The service technician confirmed the issue was resolved by replacing the power switch overlay.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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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
MDR Report Key8727633
MDR Text Key149079434
Report Number2031642-2019-04027
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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