MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-30 for STERIS SYSTEM 190A2 NA manufactured by Steris Corp..
[183518]
The instrument tray failed, causing a leak of approx 10-15 gals of chemical and water in common sub- sterial area, generating a burning type of vapor.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1017253 |
MDR Report Key | 242606 |
Date Received | 1999-09-30 |
Date of Report | 1999-09-30 |
Date of Event | 1999-09-16 |
Date Added to Maude | 1999-10-04 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | STERIS |
Generic Name | SYSTEM 190A2 |
Product Code | MCR |
Date Received | 1999-09-30 |
Model Number | SYSTEM 190A2 |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 235037 |
Manufacturer | STERIS CORP. |
Manufacturer Address | 5960 HEISLEY RD. MENTOR OH 44060 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1999-09-30 |