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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR
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RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR Back to Search Results
Model Number V1000
Device Problem Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 01march2019.Philips field service engineer (fse) confirmed the reported issue and replaced the blower mother controller printed circuit board assembly to resolve the reported issue.Unit successfully passed performance specification testing after the repair was completed.
 
Event Description
Customer reported burning smell coming from ventilator.No patient/user harm reported.Event date not specified; estimate used.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
lisa cardenas
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key8383705
MDR Text Key137863797
Report Number2031642-2019-01204
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2010
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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