FDA.reportPublic FDA data

MAUDE MDR 8178748

MDR report key
8178748
Report number
3003402518-2018-00002
Event key
0
Event type
3
Date of event
2018-11-21
Date received
2018-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JILLIAN WALKER
Address
SEESTRASSE 103 MAENNEDORF, ZH 8708 SZ
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREEDOM EVO 100PIPETTING STATION FOR CLINICAL USETECAN SCHWEIZ AGJQW10641100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-190

Event Narratives#

N

Patient 1

A TECAN FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO EVALUATE THE REPORT OF THE FRONT PANEL FALLING. THE FSE REPLACED THE GAS SPRING AS IT WAS PAST THE EXPECTED LIFETIME (I.E. 3 YEARS). ADDITIONALLY, THE FSE INSTALLED A SECOND GAS SPRING ON THE FRONT PANEL. BASED ON THE UPGRADE CONFIGURATION OF THE EVO 100, A FRONT PANEL WITH AN ADJUSTABLE SHIELD REQUIRES 2 GAS SPRINGS AS SPECIFIED IN THE SERVICE MANUAL. AT THE TIME THE INSTRUMENT WAS UPGRADED BY FIELD SERVICE, ONLY ONE GAS SPRING WAS INSTALLED IN ERROR. A CAPA HAS BEEN OPENED TO INVESTIGATE THE ISSUE. THE EVO 100 FRONT PANELS ARE MADE OF PLEXIGLASS AND ARE LIGHT (3KG) AND HAVE BEEN ASSESSED IN THE PAST TO NOT CAUSE A SERIOUS INJURY. HOWEVER, IN AN ABUNDANCE OF CAUTION, DUE TO PRIOR EVENTS ON LARGER AND HEAVIER, THOUGH SIMILAR MODELS THAT RESULTED IN MODERATE INJURIES (AND FOR WHICH MDRS WERE FILED), A MDR IS BEING FILED.

D

Patient 1

THE LABORATORY CALLED TO REPORT THAT THE DOOR HINGES COLLAPSED AND THE FRONT PANEL HIT THE OPERATOR ON THE HEAD. THERE WERE NO INJURIES (E.G. BUMPS, BRUISES, CUTS, ETC) AND NO MEDICAL ATTENTION REQUIRED. THERE WAS ONLY ONE HINGE FROM INSTALLATION.