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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 Crack (1135); Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 09sep2019.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported the internal (o2) oxygen leak, and upon further inspection found the solenoid one was leaking.Also, the bottom enclosure is cracking, no longer retaining the air/o2, and exhalation valves.There was no patient involvement.
 
Manufacturer Narrative
Date received by manufacturer: 18nov2019.Multiple unsuccessful attempts were made to gather resolution.However, no additional information was provided.If any new, relevant information is received, the complaint will be reopened.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8982078
MDR Text Key157488616
Report Number2031642-2019-08410
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
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
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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