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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860 LEICA CM1860,

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860 LEICA CM1860, Back to Search Results
Model Number 149491860US
Device Problems Fire (1245); Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
 
Event Description
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.
 
Manufacturer Narrative
Added the event problem and evaluation codes.
 
Manufacturer Narrative
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.
 
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Brand NameLEICA CM1860
Type of DeviceLEICA CM1860,
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 Key8277411
MDR Text Key134091236
Report Number8010478-2019-00002
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number149491860US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
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