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

Model Number	ECG-1350A
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the electrocardiograph device displayed inaccurate readings.No consequence or impact to the patient.
Event or Problem Description
The customer reported that the electrocardiograph device displayed inaccurate readings.No consequence or impact to the patient.
Additional Manufacturer Narrative
Details of complaint: the customer reported an ecg-1350a unit was experiencing false readings.There was no further information provided.Attempts to obtain further information were made, with no response from the customer.Service requested / performed: troubleshooting.Investigation summary: the root cause of this issue cannot be determined as there was not enough information provided by the customer.Attempts were made to follow up with the customer, but there was no response.Due to the age of this complaint, no additional information can be obtained from the customer.Since the root cause was unable to be determined, no capa is required.Without a root cause, the counter measure to prevent recurrence cannot be performed.The overall risk rating is determined to be medium.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date, g4 device bla number.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional information: b4 date of this report.D7a is this a single-use device? g2 report source.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: CARDIOFAX M
• Common Device Name: ECG-1350A
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8761393
• Report Number: 8030229-2019-00270
• Device Sequence Number: 11429323
• Product Code: DPS
• UDI-Device Identifier: 04931921110713
• UDI-Public: 04931921110713
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021
• Report Date (Section F): 07/03/2019

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 110 MO
• Event Location: Other
• Date Report to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/03/2019