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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION ECG-1350A ELECTROCARDIOGRAPH Back to Search Results
Model Number ECG-1350A
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2019
Event Type  Malfunction  
Manufacturer Narrative

The nurse reported that their ecg unit was displaying waveforms that the physicians do not agree with. The failed device was sent in for evaluation. No patient harm or injury was reported. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available. Attempts to obtain information on the devices that were used in conjunction with the ecg unit were made, but not provided.

 
Event Description

The nurse reports that their ecg unit was displaying waveforms that the physicians do not agree with.

 
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Brand NameECG-1350A
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 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 mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key8967769
MDR Text Key198335039
Report Number8030229-2019-00437
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2019
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 FDA02/10/2020
Distributor Facility Aware Date02/06/2020
Device Age59 mo
Event Location Hospital
Date Report TO Manufacturer02/10/2020
Date Manufacturer Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/05/2019 Patient Sequence Number: 1
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