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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR; VENTILATOR, CONTINUOUS
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RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR; VENTILATOR, CONTINUOUS Back to Search Results
Model Number V60
Device Problems Device Operates Differently Than Expected (2913); Output below Specifications (3004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the tidal volume too low while in use on patient.The customer reported no patient harm.The customer reported the ventilator settings were s/t mode, set ipap 12cmh2o, set epap 6cmh2o and reading of tidal volume below 200 ml.The customer reported the circuit type is a standard circuit, mask type is x1 and port is dep.The customer reported performance verification testing failed.The field service engineer reported replacement of the gas delivery system resolved the reported problem.The unit passed all applicable testing.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad CA 92011
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad CA 92011
Manufacturer Contact
dennis daniels
2271 cosmos ct.
carlsbad, CA 92011
7609187300
MDR Report Key3774402
MDR Text Key16683122
Report Number2031642-2014-00294
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2014
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2013
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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