MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-28 for THERMOLYNE DRI-BATH DB-12215E * manufactured by Barnstead/thermolyne Corp..
[22083635]
While inserting a screwdriver into adjustment screw hole in back of device, an employee was shocked. Went to er: arm red; treated with tylenol. It appears that the screw driver being used slipped off the adjustment screw and touched the incoming power contact, resulting in a shock to the pt. An electrical safety test was performed on the equipment showing the ground was intact and chassis leakage was within standards. Per engineer, device has a design flaw, in that the adjustment screw is not isolated from the power contact sufficiently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 72953 |
| MDR Report Key | 72953 |
| Date Received | 1997-02-28 |
| Date of Report | 1997-02-27 |
| Date of Event | 1997-02-18 |
| Date Facility Aware | 1997-02-19 |
| Report Date | 1997-02-27 |
| Date Reported to Mfgr | 1997-02-27 |
| Date Added to Maude | 1997-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOLYNE DRI-BATH |
| Generic Name | DRI-BATH USED IN BLOOD BANK |
| Product Code | JRG |
| Date Received | 1997-02-28 |
| Model Number | DB-12215E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 72810 |
| Manufacturer | BARNSTEAD/THERMOLYNE CORP. |
| Manufacturer Address | PO BOX 797 DUBUQUE IA 520040797 US |
| Baseline Brand Name | THERMOLYNE |
| Baseline Generic Name | BLOOD BANK DRI-BATH |
| Baseline Model No | DB12215E |
| Baseline Catalog No | DB12215E |
| Baseline ID | * |
| Baseline Device Family | DRI-BATHS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-02-28 |