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

Model Number	ECG-1350A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2017, the customer at (b)(6) reported the following issue with ecg-1350a; sn (b)(4), from cardiology: nurse reported that the pulse was reading low.Cables have been changed.Service requested: troubleshooting.Service performed: on (b)(6) 2017, nk ts noted that the nurse had measured the patient's pulse manually and verified that the unit was not reading the pulse correctly.Hospital biomed was supposed to contact nk ts back regarding troubleshooting.Nk ts called hospital but did not receive a response.No further communications from the customer were documented relating to this ticket or this device.Investigation summary: the root cause of the issue was undetermined due to insufficient/incomplete information regarding the issue resolution but could be presumed to be due to faulty cables.The overall risk of this event, taking into consideration of severity and probability, is "medium".

• Brand Name: ECG-1350A
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7081548
• Report Number: 8030229-2017-00425
• Device Sequence Number: 11125548
• Product Code: DPS
• UDI-Device Identifier: 04931921110713
• UDI-Public: 04931921110713
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Medical Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 12/04/2017

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: 11/07/2017
• Device Age: 96 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 10/29/2020
• 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: 12/04/2017