Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR Back to Search Results
Model Number V1000
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6) 2018 - philip's field service engineer (fse) evaluated the device and confirmed the reported restart error code in the log.Fse replaced the central processing unit board and ran unit for 2 days to make sure unit did not fail again.Performed completed performance assurance and all tests passed.
 
Event Description
The customer reported that the unit shut off while in use and an error code occurred indicating a restart.There was no patient or user harm reported.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date of report: 12nov2018.Date of report: 09nov2018.The customer returned the central processing unit printed circuit board assembly.Testing was performed and no failures were detected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key7813453
MDR Text Key118394101
Report Number2031642-2018-01705
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 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT CIRCUIT AND MASK: UNKNOWN
-
-