HEMOCHRON ACT MONITOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-23 for HEMOCHRON ACT MONITOR * manufactured by Itc.

Event Text Entries

[548532] A 4001 model hemochron act monitor did not turn properly; inaccurate readings. Protamine required to correct.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1041202
MDR Report Key787773
Date Received2006-06-23
Date of Report2006-06-15
Date of Event2006-05-22
Date Added to Maude2006-11-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHEMOCHRON ACT MONITOR
Generic Name*
Product CodeKQG
Date Received2006-06-23
Returned To Mfg2006-06-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key775530
ManufacturerITC
Manufacturer Address8 OLSEN AVENUE EDISON NJ * US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-06-23

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