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	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that there was heat damage inside the battery well of the telemetry transmitter.This happened despite efforts to prevent the heat damage by ensuring fresh batteries and new contacts are used as often as possible.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that there was heat damage inside the battery well of the telemetry transmitter.This happened despite efforts to prevent the heat damage by ensuring fresh batteries and new contacts are used as often as possible.No patient harm was reported.

• Brand Name: ZM-521PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 12013557
• Report Number: 2080783-2021-00340
• Device Sequence Number: 11838769
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/16/2021
• Report Date (Section F): 06/16/2021

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-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2021
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTIPLE PATIENT RECEIVER (ORG)
• Date Report Sent to FDA: 06/16/2021