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.
[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
Report Number | 1718850-2014-00316 |
MDR Report Key | 4071196 |
Report Source | 05 |
Date Received | 2014-09-02 |
Date of Report | 2014-08-06 |
Date of Event | 2014-08-05 |
Date Mfgr Received | 2014-08-06 |
Device Manufacturer Date | 2011-04-01 |
Date Added to Maude | 2014-09-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | CHERI VOORHEES, MGR |
Manufacturer Street | 14401 WEST 65TH WAY |
Manufacturer City | ARVADA CO 80004 |
Manufacturer Country | US |
Manufacturer Postal | 80004 |
Manufacturer Phone | 3034676527 |
Manufacturer G1 | SORIN GROUP DEUTSCHLAND |
Manufacturer Street | LINDBERGHSTR. 25 |
Manufacturer City | MUNICH D 80939 |
Manufacturer Country | GM |
Manufacturer Postal Code | D 80939 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | STOCKERT S3 BUBBLE DETECTOR |
Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
Product Code | KRL |
Date Received | 2014-09-02 |
Model Number | 23-07-50 |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SORIN GROUP DEUTSCHLAND |
Manufacturer Address | LINDBERGHSTR. 25 MUNICH D 80939 GM D 80939 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-09-02 |