STOCKERT S3 BUBBLE DETECTOR 23-07-50 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-02 for STOCKERT S3 BUBBLE DETECTOR 23-07-50 NA manufactured by Sorin Group Deutschland.

Event Text Entries

[16782009] Sorin group received a report the sorin s3 bubble detector was malfunctioning during a procedure. There was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5


[16941592] Sorin group (b)(4) manufactures the sorin s3 bubble detector. The incident occurred in (b)(6). The medwatch report is filed on behalf of sorin group (b)(4). The investigation is ongoing. A f/u report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1718850-2014-00316
MDR Report Key4071196
Report Source05
Date Received2014-09-02
Date of Report2014-08-06
Date of Event2014-08-05
Date Mfgr Received2014-08-06
Device Manufacturer Date2011-04-01
Date Added to Maude2014-09-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCHERI VOORHEES, MGR
Manufacturer Street14401 WEST 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer Phone3034676527
Manufacturer G1SORIN GROUP DEUTSCHLAND
Manufacturer StreetLINDBERGHSTR. 25
Manufacturer CityMUNICH D 80939
Manufacturer CountryGM
Manufacturer Postal CodeD 80939
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSTOCKERT S3 BUBBLE DETECTOR
Generic NameMONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
Product CodeKRL
Date Received2014-09-02
Model Number23-07-50
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP DEUTSCHLAND
Manufacturer AddressLINDBERGHSTR. 25 MUNICH D 80939 GM D 80939


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-02

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