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	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The biomedical engineer (bme) reported that they have a telemetry transmitter that was getting hot, and the case was cracked in a couple of places.Nihon kohden technical support (tech support) assisted them with replacing and monitoring another transmitter.This was found at set-up, and not in patient use.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter was getting hot, and the case was cracked in a couple places.This issue was discovered at setup.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was getting hot, and the case was cracked in a couple places.No harm or injury was reported.Investigation summary: customer reported that their transmitter got hot.Additional information from ticket 128138 states that the unit had physical damage and fluid intrusion.A previous investigation under irc-nka300097945 identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.A definitive root cause could not be identified as the device was not returned due to the customer reporting physical damage and fluid intrusion.A possible cause of the issue is improper battery insertion due corroded battery terminals.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 the batteries (ref tn-1231).The design change has been applied to the following serial numbers: (b)(6)- serial (b)(6) or later zm-521pa - serial (b)(6) or later zm-530pa - serial (b)(6) or later zm-531pa - serial (b)(6) or later.The complaint device zm-531pa 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: 12840496
• Report Number: 8030229-2021-01984
• Device Sequence Number: 4265663
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/07/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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: NA.; NA.
• Patient Sex: Unknown