MAUDE Adverse Event Report: HETTICH INSTRUMENTS LP; CENTRIFUGE

Model Number EBA 21

Device Problem Fire (1245)

Patient Problem No Information (3190)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Laboratory technologist was operating the hettich model eba21 centrifuge when they heard a popping-like noise come from the instrument.While the instrument was being unplugged from the electrical outlet, the technologist observed sparks, a flame, and smoke coming from the instrument.

• Type of Device: CENTRIFUGE
• Manufacturer (Section D): HETTICH INSTRUMENTS LP; 100 cummings center, ste 136l; beverly MA 01915
• MDR Report Key: 4642254
• MDR Text Key: 19090235
• Report Number: 4642254
• Device Sequence Number: 1
• Product Code: JQC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EBA 21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2015
• Patient Sequence Number: 1