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

Model Number	ECG-1350A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The office assistant reported that the unit does not seem to function correctly.The unit is not reading correctly, and the response to the patient's vitals are not coming out well.This is all the information that they had.There were no error messages.No patient harm 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.
Event or Problem Description
The office assistant reported that the unit does not seem to function correctly.The unit is not reading correctly, and the response to the patient's vitals are not coming out well.This is all the information that they had.There were no error messages.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the office assistant reported that the unit does not seem to function correctly.The unit is not reading correctly, and the response to the patient's vitals are not coming out well.This is all the information that they had.There were no error messages.No patient harm was reported.Investigation conclusion: customer reported that the unit is not reading correctly.The complaint unit was not returned for evaluation.The complaint unit has been in service since 03/01/2011.A review of the history of the serial number identified no other reports against the device.Based on the available information, a definitive root cause could not be identified.Ecg units may fail and give inaccurate readings should the hardware or cables be damaged due to mishandling, aging, or wear and tear.As ecg units are portable devices, physical damage is likely to occur.The device has been in service since 2011 with no reported issues and wear and tear may be a contributing factor to the issue.In case of damage on the device, replacement or repair of the defective ecg unit would be needed to resolve the issue.Without the complaint unit, a definitive root cause could not be identified, and corrections to address the root cause could not be identified.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 02/02/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 02/14/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 02/19/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
Event or Problem Description
The office assistant reported that the unit does not seem to function correctly.The unit is not reading correctly, and the response to the patient's vitals are not coming out well.This is all the information that they had.There were no error messages.No patient harm was reported.

• Brand Name: ECG-1350A
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2-314 ; JA 370-2314
• MDR Report Key: 16464985
• Report Number: 8030229-2023-03355
• Device Sequence Number: 7774406
• Product Code: DPS
• UDI-Device Identifier: 04931921110713
• UDI-Public: 04931921110713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECG-1350A
• Device Catalogue Number: ECG-1350A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown