MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SURGICAL CART P/N 9606 manufactured by Karl Storz.
Report Number | 9145616 |
MDR Report Key | 9145616 |
Date Received | 2019-10-02 |
Date of Report | 2019-05-09 |
Date of Event | 2018-12-01 |
Report Date | 2019-09-13 |
Date Reported to FDA | 2019-09-13 |
Date Reported to Mfgr | 2019-10-02 |
Date Added to Maude | 2019-10-02 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SURGICAL CART P/N 9606 |
Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
Product Code | BZN |
Date Received | 2019-10-02 |
Model Number | 9606 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KARL STORZ |
Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-02 |