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

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.

• Brand Name: ECG-1350A
• Type of Device: ELECTROCARDIOGRAPH
• 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 Key: 7081548
• MDR Text Key: 94492104
• Report Number: 8030229-2017-00425
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K072217
• Number of Events Reported: 1
• 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 Received: 12/04/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: ECG-1350A
• Device Catalogue Number: ECG-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 FDA: 12/04/2017
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 96 mo
• Event Location: Hospital
• Date Report TO Manufacturer: 12/04/2017
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/14/2009
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse