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 |