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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1860

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LEICA BIOSYSTEMS NUSSLOCH LEICA CM1860 Back to Search Results
Model Number 149491860US
Device Problems Fire (1245); Use of Device Problem (1670)
Patient Problems Burn(s) (1757); Injury (2348)
Event Date 01/23/2019
Event Type  Injury  
Event Description
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.
 
Event Description
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.
 
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Brand NameLEICA CM1860
Type of DeviceLEICA CM1860
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH
heidelberger strasse 17-19
nussloch, 69226
GM 69226
MDR Report Key8318778
MDR Text Key135496742
Report Number1423337-2019-00003
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number149491860US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/15/2019
Distributor Facility Aware Date01/23/2019
Event Location Other
Date Report to Manufacturer03/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/07/2019 Patient Sequence Number: 1
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