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
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.
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.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.Multiple patient receiver (org): model: ni, sn: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter had heat damage inside the battery well of the transmitter.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter had heat damage inside the battery well of the transmitter.No harm or injury was reported.Investigation summary: a previous nkc investigation identified that the incorrect insertion of the batteries may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the battery and device.The operator's manual provides instructions on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref tn-1231).The design change has been applied to the following serial numbers: (b)(6) or later (b)(6) - serial (b)(6) or later (b)(6) - serial (b)(6) or later (b)(6) - serial (b)(6) or later.The complaint device (b)(6) sn (b)(6) was made prior to this change.A design change has been implemented to the product to prevent short circuit of the battery during battery insertion.

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12013362
• Report Number: 8030229-2021-00340
• Device Sequence Number: 4439917
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MULTIPLE PATIENT RECEIVER (ORG); MULTIPLE PATIENT RECEIVER (ORG)
• Patient Sex: Unknown