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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 Problems Occlusion Within Device (1423); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2017.
 
Event Description
The customer reported that the unit shutdown and alarmed safety valve occlusion (svo) while being used on a patient.The device was in use for therapy.There was patient involvement but there was no patient harm or injury reported.
 
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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)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key6574870
MDR Text Key75555304
Report Number2031642-2017-01664
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 faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/24/2017
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 04/24/2017
Initial Date FDA Received05/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2007
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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