MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number	ZM-521PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter is overheating during use on patient, no patient harm occurred, the unit just got warm.The biomedical engineer stated he wanted to return the unit and get a replacement unit but has not returned the device to date.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if or when additional information becomes available.(b)(4).
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter is overheating during use on patient, no patient harm occurred, the unit just got warm.

• Brand Name: ZM-521PA
• Common Device Name: TRANSMITTER
• 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: 11673280
• Report Number: 2080783-2021-00225
• Device Sequence Number: 19707120
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/15/2021
• Report Date (Section F): 04/15/2021

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-521PA
• Device Catalogue Number: ZM-521PA
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2021
• 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: 04/15/2021