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

Model Number ECG-1350A

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the electrocardiograph (ecg) gave inaccurate readings.They would test it on a patient 5-8 times, and by the 8th time, the readings would be correct and working.They have tried changing leads and cables, but it would still give incorrect readings until the 7th- 8th try.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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 01/19/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 01/24/2024 emailed the bme for all information in the ni list above: the bme replied, the patient information was unknown.

Event Description

The biomedical engineer (bme) reported that the electrocardiograph (ecg) was giving inaccurate readings.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the electrocardiograph (ecg) was giving inaccurate readings.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the electrocardiograph (ecg) gave inaccurate readings.They would test it on a patient 5-8 times, and by the 8th time, the readings would be correct and working.They have tried changing leads and cables, but it would still give incorrect readings until the 7th- 8th try.No patient harm was reported.Investigation summary: we were unable to confirm the reported issue of incorrect readings, as there were no incorrect reading errors found during the evaluation of the device.However, we confirmed a secondary issue with the device due to a bad battery pack.The unit would turn off when unplugged for less than 30 (thirty) minutes.Due to the battery pack being used for more than 2 (two) years, it can lead to wear and tear damage, cause power-related issues, and lead to inaccurate readings when such hardware fails.The battery pack is being replaced to resolve the secondary issue.Some potential causes of ecg incorrect reading issues, which are not limited to hardware and battery issues, damage from misuse or aging, lead placement, and incorrect settings, are often a result of user error.A review of historical data for the device did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.Moreover, this was found to be the only issue at the facility in the past 3 (three) years for this device and issue.Trending will continue to be monitored.Attempt # 1: 01/19/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 01/24/2024 emailed the bme for all information in the ni list above: the bme replied, the patient information was unknown.

• Brand Name: ECG-1350A
• Type of Device: 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18676332
• MDR Text Key: 336069709
• Report Number: 8030229-2024-04145
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: ECG-1350A
• Device Catalogue Number: ECG-1350A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1