ORTHO SUMMIT SAMPLE HANDLING SYSTEM 7003009 936400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for ORTHO SUMMIT SAMPLE HANDLING SYSTEM 7003009 936400 manufactured by Hamilton Bonaduz Ag.

Event Text Entries

[611877] The ortho summit sample handling system instrument reportedly did not pipette sample/reagent and did not generate an error message. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2007-70012
MDR Report Key830713
Date Received2007-01-18
Date of Report2007-01-18
Date of Event2006-12-19
Date Added to Maude2007-03-27
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHO SUMMIT SAMPLE HANDLING SYSTEM
Generic NameSAMPLE PIPETTER
Product CodeJTQ
Date Received2007-01-18
Model Number7003009
Catalog Number936400
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key818065
ManufacturerHAMILTON BONADUZ AG
Manufacturer Address* BONADUZ SZ CH 7402
Baseline Brand NameORTHO SUMMIT SAMPLE HANDLER
Baseline Generic NameSAMPLE HANDLER
Baseline Model No7003009
Baseline Catalog No936400
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.