MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-13 for SHANDON-LIPSHAW 222 * manufactured by Shandon-lipshaw.
[87041]
It is suspected that the paraffin reached the flash point then caught fire, as a consequence of a faulty thermostat. This incident was duplicated by bio-med department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 144359 |
| MDR Report Key | 144359 |
| Date Received | 1998-01-13 |
| Date of Report | 1997-10-14 |
| Date of Event | 1997-09-15 |
| Date Facility Aware | 1997-10-14 |
| Report Date | 1997-10-14 |
| Date Reported to Mfgr | 1997-10-14 |
| Date Added to Maude | 1998-01-20 |
| 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 | SHANDON-LIPSHAW |
| Generic Name | PARAFFIN DISP. |
| Product Code | IMC |
| Date Received | 1998-01-13 |
| Model Number | 222 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | MFG. CODE 1389 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 140771 |
| Manufacturer | SHANDON-LIPSHAW |
| Manufacturer Address | 171 INDUSTRY DR. PITTSBURGH PA 15275 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-13 |