MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number	ZM-520PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter started to heat up and got too hot to touch / hold.No patient harm 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.Additional device information: concomitant medical device: the following devices were being used in conjunction with the telemetry transmitter.Central nurse's station: model: cns-6201a, sn: (b)(4).
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter started to heat up and got too hot to touch / hold.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter started to heat up and got too hot to touch or hold.No patient harm was reported.Service requested / performed: evaluation / repair: the reported issue was not duplicated by nihon kohden repair center (nk rc).During the evaluation, corrosion and residue was found on the battery contacts and case.There was also fluid intrusion to the main board.Investigation summary: as per the hazard analysis document 0704-905438f, the overheating of the battery compartment could be caused due to a number of reasons, such as: ·the battery is inserted in a wrong polarity causing overcurrent ·battery is inserted forcibly, causing fire due to short-circuit of +/- terminals ·short-circuit between the +/- battery terminals ·user does not handle nimh secondary battery and a battery charger properly, causing a short-circuit of the +/- terminals investigation determined that the reported issue could have been caused due to incorrect usage and maintenance of nk device.No further investigation is needed through the capa process.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter started to heat up and got too hot to touch or hold.No patient harm was reported.

• Brand Name: ZM-520PA
• 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 ; 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: 10242149
• Report Number: 8030229-2020-00355
• Device Sequence Number: 11437421
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/29/2022
• Report Date (Section F): 07/07/2020

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2020
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2017
• 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: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6)
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/07/2020