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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 Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 21may2019.A follow-up report will be submitted once the evaluation is complete.
 
Event Description
The customer reported error post timer/24v failure.Unit shut down while providing therapy.The unit was in clinical use at the time the reported issue was discovered.However, there was no harm to the patient or the user.
 
Manufacturer Narrative
Date of report: 14jun2019.Date received by manufacturer: 07jun2019.The manufacturer¿s technical services (ts) confirmed the reported issue.The customer was advised the power supply harness will be required to repair unit.The customer replaced the defective power supply to address the reported problem.The unit successfully passed the required performance verification test.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 Key8634101
MDR Text Key145921594
Report Number2031642-2019-03170
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 05/13/2019
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
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received05/22/2019
Supplement Dates Manufacturer Received05/13/2019
Supplement Dates FDA Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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