MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-08-17 for AMSCO 430 FL-XXXX manufactured by Steris Canada Corp..
[158183]
A thermostat failure caused sump water to overheat and evaporate. Steam was escaping from both doors when operator went to open door. The operator suffered from 2nd degree burn to right arm. The operator informed supervisor of washer malfunction. The supervisor then opened door and suffered 1st degree burns to face and knuckles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-1999-00002 |
| MDR Report Key | 236766 |
| Report Source | 06 |
| Date Received | 1999-08-17 |
| Date of Report | 1999-08-13 |
| Date of Event | 1999-07-19 |
| Date Mfgr Received | 1999-07-19 |
| Device Manufacturer Date | 1992-10-01 |
| Date Added to Maude | 1999-08-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO |
| Generic Name | RELIANCE SERIES WASHER/DISINFECTOR |
| Product Code | ECG |
| Date Received | 1999-08-17 |
| Model Number | 430 |
| Catalog Number | FL-XXXX |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229448 |
| Manufacturer | STERIS CANADA CORP. |
| Manufacturer Address | 415 RUE DES ALLEGHANYS BEAUPORT, QUEBEC CA G1C 4N4 |
| Baseline Brand Name | AMSCO |
| Baseline Generic Name | RELIANCE SERIES WASHER |
| Baseline Model No | 430 |
| Baseline Catalog No | FL-XXXX |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921996 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-17 |