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

Model Number ECG-1350A

Device Problem Output Problem (3005)

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2017

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 94492104
• Report Number: 8030229-2017-00425
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/04/2017,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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: 12/04/2017
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 96 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2017
• Date Manufacturer Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1