• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN CORPORATION ECG-1350A ELECTROCARDIOGRAPH Back to Search Results
Model Number ECG-1350A
Device Problem Output Problem (3005)
Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2017
Event Type  Malfunction  
Manufacturer Narrative

The nurse reports that the pulse is reading low on the ecg-1350a. They measured the patient's pulse manually and verified the ecg is not reporting the pulse correctly. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.

 
Event Description

The nurse reports that the pulse is reading low on the ecg-1350a. They measured the patient's pulse manually and verified the ecg is not reporting the pulse correctly.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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, gunma 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 Key7081548
MDR Text Key94492104
Report Number8030229-2017-00425
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 MEDICAL ASSISTANT
Type of Report Initial,Followup
Report Date 12/04/2017,10/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2017
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 FDA12/04/2017
Distributor Facility Aware Date11/07/2017
Device Age96 mo
Event Location Hospital
Date Report TO Manufacturer12/04/2017
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/14/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-