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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the battery contacts on the transmitter were smoking.The customer sent the device in on (b)(6) 2020 and it is currently awaiting evaluation and repair.The issue was found at setup.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 customer reported that the battery contacts on the transmitter were smoking.
Event or Problem Description
The customer reported that the battery contacts on the transmitter were smoking.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the battery contacts on the transmitter were smoking.No harm or injury was reported.Investigation summary: the customer stated that the battery contacts looked rusty and in poor condition.The transmitter operated within specifications when the battery contacts were smoking.Nihon kohden technical support (nk ts) initiated a repair for the device.Nihon kohden repair center's (nk rc) evaluation could not duplicate the reported issue.However, the battery contacts were corroded.An exchange unit was sent to the customer.The root cause determined to be fluid intrusion (corroded battery contacts).The device was in use on a patient at the time of the incident, but no patient harm was reported.A review of the device history found that this is not a trending issue.A previous investigation 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.Another possible cause of the issue is improper battery insertion.It is remote or unlikely to cause patient death or life-threatening permanent impairment.This is because the maximum exterior temperature is below the minimum temperature that can cause a burn after prolonged (greater than 5 hours) skin exposure.The operator's manual provides instruction 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 (b)(4)).The design change has been applied to the following serial numbers: (b)(6); serial (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 a design change has been implemented to the product to prevent short circuit of the battery during battery insertion.The complaint device was manufactured prior to this change.

• 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 ; 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: 10491904
• Report Number: 8030229-2020-00502
• Device Sequence Number: 4016426
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023
• Report Date (Section F): 09/03/2020

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-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2020
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2016
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/03/2020