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.
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.Investigation summary: based on the available information, a definitive root cause could not be identified.Possible causes of the issue are improper battery insertion and defective battery.The operator's manual provides instruction on how to properly insert the batteries on the device.A design change has been made to prevent overheating by short circuit caused by improper insertion of batteries.No further corrective actions necessary.
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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11672329
• Report Number: 8030229-2021-00225
• Device Sequence Number: 19707123
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown