CARDIOFAX M ECG-1350A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-03 for CARDIOFAX M ECG-1350A manufactured by Nihon Kohden Corporation.

MAUDE Entry Details

Report Number8030229-2019-00270
MDR Report Key8761393
Date Received2019-07-03
Date of Report2019-07-03
Date of Event2019-06-05
Date Facility Aware2019-06-05
Report Date2019-07-03
Date Reported to FDA2019-07-03
Date Reported to Mfgr2019-07-03
Date Mfgr Received2019-06-05
Device Manufacturer Date2010-03-08
Date Added to Maude2019-07-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHAMA MOONMAN
Manufacturer StreetSAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2
Manufacturer CityKUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8580
Manufacturer CountryJA
Manufacturer Postal359-8580
Manufacturer G1NIHON KOHDEN TOMIOKA CORPORATION
Manufacturer Street1-1 TAJINO ATTN: SHAMA MOOMAN
Manufacturer CityTOMIOKA CITY, 370-2314
Manufacturer CountryJA
Manufacturer Postal Code370-2314
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameCARDIOFAX M
Generic NameECG-1350A
Product CodeDPS
Date Received2019-07-03
Model NumberECG-1350A
Catalog NumberECG-1350A
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age110 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIHON KOHDEN CORPORATION
Manufacturer Address1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN 161-8560 JA 161-8560


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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