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	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the transmitter got hot and smoked.They were not able to recover the batteries that were connected to the transmitter so that they could be sent in for a proper investigation.They stated that this was reported by the nurses during the night shift.This was found at set-up and not in patient use.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.The following fields are not applicable (na) to the mdr report: patient information, outcomes of adverse event, revelant test/history, lot number & expiration, implant/explant date, reprocessor name/address, medical products, user facility, device bla number, follow-up type,remedial action.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter got hot and smoked.They were not able to recover the batteries that were connected to the transmitter so that they could be sent in for a proper investigation.They stated that this was reported by the nurses during the night shift.This was found at set-up and not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the transmitter got hot and was smoking.This was found at set-up and was not in patient use.Investigation summary: the complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the reported issue.A previous nkc 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.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.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 (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.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.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter got hot and was smoking.This was found at set-up and was not in patient use.

• 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: 13491727
• Report Number: 8030229-2022-02455
• Device Sequence Number: 19861966
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2018
• 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