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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 Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Event date: (b)(6) 2019.Date of this report: 06jan2020.
 
Event Description
The customer reported that the screen was cracked.There was no patient involvement.
 
Manufacturer Narrative
G4: 16jan2020.B4: (b)(6) 2020.After numerous attempts to obtain information on the event, the patient and the repair, this complaint is being closed.If further information is obtained this complaint will be reopened.The determination could not be made that the device failed to meet specifications.Though the unit was being used on a patient at the time the reported issue occurred, there was no patient harm.There is no relationship of the device to the reported problem.Part was not returned to failure investigation (fi).The root cause cannot be determined until the device is returned and investigated.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 Key9555287
MDR Text Key179547791
Report Number2031642-2020-00070
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV1000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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