MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for LEICA CM1860 149491860US manufactured by Leica Biosystems Nussloch.
[135496742]
On (b)(6) 2019, a customer reported that while using an instant cooling agent (spray) on the freezing shelf in their cm1860 cryostat, the spray ignited causing combustion with fire to occur. This resulted in the user's face and eyebrows being burnt. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[140025467]
The affected instrument was inspected at the customer site by a leica biosystems regional technical specialist. The customer was advised that any flammable sprays shall not be used within the instrument. The investigation concluded that the potential cause was an applications issue due to the use of an unauthorized flammable spray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2019-00003 |
| MDR Report Key | 8318778 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-01-23 |
| Date Facility Aware | 2019-01-23 |
| Report Date | 2019-03-15 |
| Date Reported to FDA | 2019-03-15 |
| Date Reported to Mfgr | 2019-03-15 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEICA CM1860 |
| Generic Name | LEICA CM1860 |
| Product Code | IDP |
| Date Received | 2019-02-07 |
| Model Number | 149491860US |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |