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); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the unit was waiting to connect to a patient, and the staff noticed a small amount of "smell" coming from the unit.When they opened the door, they found that the battery had expanded inside the unit.The customer had thrown the battery away but had taken a picture of it before doing so.Tech support (ts) had requested a picture of the battery.The device was not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the unit was waiting to connect to a patient, and the staff noticed a small amount of "smell" coming from the unit.When they opened the door, they found that the battery had expanded inside the unit.The customer had thrown the battery away but had taken a picture of it before doing so.Tech support (ts) had requested a picture of the battery.The device was 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.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the unit was waiting to connect to a patient, and the staff noticed a small amount of "smell" coming from the unit.When they opened the battery door, they found that the battery had expanded/burst inside the unit.The customer had thrown the battery away.No harm or injury was reported.Investigation summary: customer was also unable to provide a picture of the battery.The complaint unit was returned to nk and it was inspected by nk repair center.Nk repair center was unable to duplicate the issue.The reported defect could not be confirmed.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue are improper insertion of the battery, and a defective battery.Improper 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 battery.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)- serial (b)(6)- serial (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.
Event or Problem Description
The biomedical engineer (bme) reported that the unit was waiting to connect to a patient, and the staff noticed a small amount of "smell" coming from the unit.When they opened the battery door, they found that the battery had expanded/burst inside the unit.The customer had thrown the battery away but had taken a picture of it before doing so.Tech support (ts) requested a picture of the battery.The device 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: 14229796
• Report Number: 8030229-2022-02780
• Device Sequence Number: 4406472
• 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): 05/03/2023

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: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Sex: Unknown