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

Model Number ECG-1350A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that their ecg unit was displaying waveforms that the physicians do not agree with.The failed device was sent in for evaluation.No patient harm or injury 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.Attempts to obtain information on the devices that were used in conjunction with the ecg unit were made, but not provided.

Event Description

The nurse reports that their ecg unit was displaying waveforms that the physicians do not agree with.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer nurse stated that ecg device is showing waveforms that the doctors did not agree with.Customer was not able to provide further details nor troubleshoot.On (b)(6) 2019, customer responded to follow up attempt stating to "disregard" the incident.Service was no longer needed.The issue was previously reported under ticket 55109 on (b)(6) 2019 with the following information: "biomed bruce calling because the staff using the device explained it is not printing the same way as a 3rd party device prints the ecg output.The printout provided by the staff and attached to the ticket shows the 3rd party device prints out the 12-lead ecg in one continuous line and markers indicating a lead change, where the nk device prints out with a broken line when the lead selection changes.The device printout data indicates it is functioning properly and this is a preference by the nursing staff to have it print differently if that is possible.Bruce does not know if this is due to new staff, if it ever printed different, or if it was changed by someone" investigation summary: ecg-1350a was put into service (b)(6) 2015.Service history shows the following no other reported incidents besides what was stated above.Due to the lack of information available.An investigation into the reported issue is not possible at this time.No risk assessment could be performed.The following fields are not applicable (na) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 f10 g6 g8 h7 h9 the following field contains no information (ni), as attempts to obtain information were made but not provided: d11 & c2: concomitant medical products additional information: b4.Date of this report f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? h6.Event problem and evaluation codes h10.Additional manufacturer narrative corrected information: b2 adverse event or product problem "death" was selected by accident in the initial mdr and is now deselected.

Event Description

The nurse reports that their ecg unit was displaying waveforms that the physicians did not agree with.

• 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: 8967769
• MDR Text Key: 198335039
• Report Number: 8030229-2019-00437
• 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: 02/10/2020

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2020
• Distributor Facility Aware Date: 02/06/2020
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death