MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

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.

• Brand Name: LEICA CM1950
• Type of Device: LEICA 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 Key: 8161565
• MDR Text Key: 130314327
• Report Number: 8010478-2018-00005
• Device Sequence Number: 0
• Product Code: IDP
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• 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 Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 1491950C03JR1601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other