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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V1000
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported oxygen valve stuck closed occurrence.No patient involvement reported.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
Correct contact address (b)(4).Philips field service was declined by the customer.As such, the manufacturer could not duplicate the reported problem.The device was not returned for investigation.The customer repaired the unit by replacing the o2 sensor; the device is back in service.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
betty harris
2271 cosmos court
carlsbad, CA 92011
MDR Report Key4787054
MDR Text Key5802036
Report Number2031642-2015-00924
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 Health Professional,User Facility,health professional,use
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 05/06/2015
Initial Date FDA Received05/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2003
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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