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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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SORIN GROUP DEUTSCHLAND STOCKERT S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 48-40-00
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2014
Event Type  Other  
Event Description
Sorin group received a report that the s5 system alarmed and displayed an error message during a procedure.There was no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
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Brand Name
STOCKERT S5 SYSTEM
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GM 
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GM  
Manufacturer Contact
cheri voorhees, manager
14401 west 65th way
arvada, CO 80004
3034676527
MDR Report Key4379364
MDR Text Key16628312
Report Number1718850-2014-00482
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/24/2014
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 Number48-40-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received12/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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