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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950 Back to Search Results
Model Number 1491950C03JR1601
Device Problems Fire (1245); Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative
The investigation revealed the following: the incident was user related due to a wrong application from the customer site. He did use a pathological tissue quick freezing spray, named white freezer s, which is a flammable substance, and not recommended for use in the leica cm1950, according to the instructions for use. A customer facing letter will be sent to the customer with a recommendation in the future not to use flammable substances in the leica cm1950 when it is turned on and plugged in.
 
Event Description
A customer reported to leica biosystems that on (b)(6) 2018 combustion with fire occurred during the usage of an instant cooling agent on the freezing shelf in their cm1950. On (b)(6) 2018 the customer informed leica biosystems that he was burned on his arm and the hair on his forehead. He was wearing a mask and goggles which prevented him from being burned on his face. Medical treatment was necessary.
 
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Brand NameLEICA CM1950
Type of DeviceLEICA CM1950
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelberger strasse 17-19
nussloch, 69226
GM 69226
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch, 69226
GM   69226
MDR Report Key8161565
MDR Text Key130314327
Report Number8010478-2018-00005
Device Sequence Number0
Product Code IDP
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number1491950C03JR1601
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2013
Is the Device Single Use? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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