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: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
  • 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
 

SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 24-40-45
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Patient involvement (2648)
Event Date 01/28/2015
Event Type  Other  
Event Description
Sorin group deutschland received a report that the s5 gas blender was not delivering air properly during maintenance.There was no patient involvement.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender was not delivering air properly during maintenance.The investigation is ongoing.A follow up report will be sent when the investigation is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
S5 GAS BLENDER SYSTEM
Type of Device
GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindbergh strasse 25
munich D 80 939
GM  D 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindbergh strasse 25
munich D 80 939
GM   D 80939
Manufacturer Contact
cheri voorhees, mgr.
14401 w 65th way
arvada, CO 80004
3034676527
MDR Report Key4564633
MDR Text Key5561361
Report Number9611109-2015-00033
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Unknown
Remedial Action Other
Type of Report Initial
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number24-40-45
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-