MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-11-11 for AMSCO 430 FL-XXXX manufactured by Steris Canada Corp..
[15005615]
A. Reported info: faulty thermostat caused sump water to overheat and evaporate. The steam escaped the chamber when the access door was opened and the operator was slightly burned on the left forearm (not a serious injury). B. Reportable malfunction: steam caused by sump water evaporation will escape from washer and might cause severe burns if all of the following condition are met simultaneously: thermostat failure with sump water heating during thermal rinse phase; operator not following safety warning and opens chamber door before cycle completion. Operator not wearing recommended protective equipment (gloves, face shield) as per labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-1998-00002 |
| MDR Report Key | 197368 |
| Report Source | 06 |
| Date Received | 1998-11-11 |
| Date of Report | 1998-11-06 |
| Date of Event | 1998-10-09 |
| Date Mfgr Received | 1998-10-12 |
| Device Manufacturer Date | 1992-05-01 |
| Date Added to Maude | 1998-11-19 |
| 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 |
| Product Code | ECG |
| Date Received | 1998-11-11 |
| 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 | 191755 |
| 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 | 1998-11-11 |