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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CARDIOFAX M ECG-1350A

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NIHON KOHDEN CORPORATION CARDIOFAX M ECG-1350A Back to Search Results
Model Number ECG-1350A
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  Malfunction  
Manufacturer Narrative

The customer reported that the electrocardiograph device displayed inaccurate readings. No consequence or impact to the patient was reported. Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.

 
Event Description

The customer reported that the electrocardiograph device displayed inaccurate readings. No consequence or impact to the patient.

 
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Brand NameCARDIOFAX M
Type of DeviceECG-1350A
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, 370-2 314
JA 370-2314
Manufacturer Contact
shama moonman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key8761393
MDR Text Key150249127
Report Number8030229-2019-00270
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072217
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 07/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberECG-1350A
Device Catalogue NumberECG-1350A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2019
Distributor Facility Aware Date06/05/2019
Device Age110 mo
Event Location Other
Date Report TO Manufacturer07/03/2019
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/08/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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