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

Model Number ECG-1350A

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2019

Event Type  malfunction  

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 Description

The customer reported that the electrocardiograph device displayed inaccurate readings.No consequence or impact to the patient.

Event Description

The customer reported that the electrocardiograph device displayed inaccurate readings.No consequence or impact to the patient.

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
• Type of Device: 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
• MDR Text Key: 150249127
• Report Number: 8030229-2019-00270
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 04931921110713
• UDI-Public: 04931921110713
• Combination Product (y/n): N
• PMA/PMN Number: K072217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/03/2019,07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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