MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-11-07 for HOPLAB INC 430 FL-0228 manufactured by Hoplab Inc..
[7761230]
The evaluation summary referred to in section h. 3 was initially attached with first report.
Patient Sequence No: 1, Text Type: N, H10
[21626977]
Reported info: faulty thermostat caused sump water to overheat and susporate. The steam escaped the chamber when the access door was opened and the operator was slightly burned to the left hand knuckles (not a serious injury). Reportable malfunction: steam caused by the sump waster evaporation will escape from washer and night cause severe burns if all of the following conidtions are met simultaneously. Thermostat failure with contractor closed duting the thermal rinse phase; operator not following warning labels and opens chamber door before cycle completion; operator not wearing recommended protective equipment (gloves and face shield) as per labeling of washer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-1996-00001 |
| MDR Report Key | 48963 |
| Report Source | 07 |
| Date Received | 1996-11-07 |
| Date of Report | 1996-11-06 |
| Date of Event | 1996-10-03 |
| Date Mfgr Received | 1996-10-07 |
| Device Manufacturer Date | 1990-06-01 |
| Date Added to Maude | 1996-11-18 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOPLAB INC |
| Generic Name | RELIANCE SERIES WASHER |
| Product Code | ECG |
| Date Received | 1996-11-07 |
| Model Number | 430 |
| Catalog Number | FL-0228 |
| Lot Number | NA |
| ID Number | 900/1485 (ORDER #) |
| Operator | OTHER |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 49721 |
| Manufacturer | HOPLAB INC. |
| Manufacturer Address | 415 RUE ALEGANIS BEAUPORT (QUEBEC) CA |
| 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 | 1996-11-07 |