HEMOCHRON JR HE-JR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-11 for HEMOCHRON JR HE-JR manufactured by International Technidyne Corp..

Event Text Entries

[42983] The user facility has suggested that 148 days prior to notification the instrument produced inaccurate readings "in some instances", which may have resulted in improper administration of anticoagulant to this pt which, in turn, may have contributed to bleeding in a very high risk pt. Despite requests, no further info regarding this event has been received and co is unable to clarify the relationship, if any, of this event and the instrument or the appropriateness of the use of this instrument in this particular setting. The reports provided by this user-facility are the only ones related to misadministration of anticoagulant and possible bleeding using the instrument. The mfr will continue to seek clarification of the event and provide follow-up as appropriate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2248721-1996-00004
MDR Report Key63794
Report Source05,06
Date Received1997-01-11
Date of Report1997-01-10
Date of Event1996-06-11
Date Mfgr Received1996-12-12
Date Added to Maude1997-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOCHRON JR
Generic NamePOINT-OF-CARE ACT TESTER
Product CodeKQG
Date Received1997-01-11
Model NumberHEMOCHRON JR
Catalog NumberHE-JR
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key63951
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer Address6 OLSEN AVE EDISON NJ 08820 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-01-11

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