ZM-521PA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-26 for ZM-521PA manufactured by Nihon Kohden Corporation.

MAUDE Entry Details

Report Number8030229-2020-00111
MDR Report Key9753077
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-26
Date of Report2020-02-25
Date of Event2020-02-11
Date Facility Aware2020-02-11
Report Date2020-02-25
Date Reported to FDA2020-02-25
Date Reported to Mfgr2020-02-25
Date Mfgr Received2020-02-11
Device Manufacturer Date2015-11-18
Date Added to Maude2020-02-26
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 MOOMAN
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, GUNMA 370-2314
Manufacturer CountryJA
Manufacturer Postal Code370-2314
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameZM-521PA
Generic NameTRANSMITTER
Product CodeDRT
Date Received2020-02-26
Returned To Mfg2020-02-19
Model NumberZM-521PA
Catalog NumberZM-521PA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age51 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNIHON KOHDEN CORPORATION
Manufacturer Address1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN TOKYO, 161-8560 JA 161-8560


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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