MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number	ZM-520PA
Medical Device Problem Codes	Computer Software Problem (1112); Data Problem (3196); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.Nihon kohden continues to investigate the reported event.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b d10 g1 - g8 h1- h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6, b7 attempt #1: 01/22/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs and other relevant history: no reply was received.Attempt #2: 02/01/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.Attempt #3: 02/08/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.
Event or Problem Description
The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.

• Brand Name: ZM-520PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• MDR Report Key: 11335638
• Report Number: 2080783-2021-00083
• Device Sequence Number: 19066254
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 4931921115077
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021
• Report Date (Section F): 02/16/2021

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: ZM-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2021
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2021
• 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: 02/16/2021