MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-25 for LEICA CM1860 149491860US manufactured by Leica Biosystems Nussloch Gmbh.
[134091236]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[134091237]
A customer reported to leica biosystems that on (b)(6) 2019 combustion with fire occurred during the usage of an instant cooling agent on the freezing shelf in their cm1860. "during" the customer was spraying inside the unit, she burnt her face and eyebrows. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[140025559]
Added the event problem and evaluation codes.
Patient Sequence No: 1, Text Type: N, H10
[140028252]
Removed the age of (b)(6) years, because this age was not exactly provided. The date have been changed into (b)(6) 2019, because that was the day the report was submitted to fda. Common device name: instrument was changed into cm1860 as well. The affected instrument was inspected at the customer site by a leica biosystems regional technical specialist. Based on the evaluation conducted, the instrument is in a good condition and the unit was functioning to factory specification. The customer uses a third party for regular service. The customer stated they were going to have the third party perform a pm prior to using the affected instrument again. The regional technical specialist had a discussion with the customer that any flammable sprays shall not be used within the instrument. As result of the customer visit, the customer is now using leica "frostbite," a non-flammable freezing spray. It was concluded by the regional technical specialist that the potential cause of the incident was an application issue due to use of an unauthorized flammable spray.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2019-00002 |
| MDR Report Key | 8277411 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-25 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2016-01-13 |
| Date Added to Maude | 2019-01-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1860 |
| Generic Name | LEICA CM1860, |
| Product Code | IDP |
| Date Received | 2019-01-25 |
| Model Number | 149491860US |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-25 |