FREEDOM EVO-2 200 10641202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-04-02 for FREEDOM EVO-2 200 10641202 manufactured by Tecan Schweiz Ag.

Event Text Entries

[5623142] A laboratory employee was injured when the adjustable front panel door on the instrument fell from an open position. The operator sustained a fracture to elbow and required medical attention at an urgent care facility. The laboratory reported that the front panel was falling very easily from an open position and had fallen several times before on employee's shoulders and head; however, there had been no injuries. This was the first report to tecan of the problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	1037985-2015-00001
MDR Report Key	4660168
Report Source	99
Date Received	2015-04-02
Date of Report	2015-04-02
Date of Event	2015-03-10
Date Facility Aware	2015-03-10
Report Date	2015-04-02
Date Reported to FDA	2015-04-02
Date Reported to Mfgr	2015-03-10
Date Added to Maude	2015-04-07
Event Key	0
Report Source Code	Distributor report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	OTHER HEALTH CARE PROFESSIONAL
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	3
Event Type	3
Type of Report	3

Device Details

Brand Name	FREEDOM EVO-2 200
Generic Name	PIPETTING STATION FOR CLINICAL USE
Product Code	JQW
Date Received	2015-04-02
Catalog Number	10641202
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	7 YR
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	TECAN SCHWEIZ AG
Manufacturer Address	MAENNEDORF, ZUERICH SZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-04-02