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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 Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported the backup battery was not lasting too long. The fse reported there was no patient involvement.
 
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Brand NameESPRIT VENTILATOR
Type of DeviceVENTILATOR
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
wendy chadbourne
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key6114889
MDR Text Key60688149
Report Number2031642-2016-03157
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2007
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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