MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number	ZM-521PA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter had battery heat damage and the metal springs inside the battery compartment were melted from the heat.This transmitter also had a white lcd screen.The device will be returned for evaluation.This device was not in patient use at the time.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 reported that the telemetry transmitter had battery heat damage and the metal springs inside the battery compartment were melted from the heat.This transmitter also had a white lcd screen.The device will be returned for evaluation.This device was not in patient use at the time.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer reported that the telemetry transmitter had battery heat damage and the metal springs inside the battery compartment were melted from the heat.This transmitter also had a white lcd screen.The device was sent to nka for exchange.Service requested / performed: exchange.Investigation summary: the root cause is determined to be transmitter design because the manufacturer did not foresee the possibility of short circuit from incorrect insertion of the battery by the user.An nkc investigation was performed under (b)(4) and concluded that incorrect insertion of the battery may cause the battery terminal spring to break the coating of the battery, leading to a short circuit.The overall risk of this event is medium.The reported issue does not require further investigation through capa process.A new design change has been introduced to the transmitter's rear case, adding an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter had battery heat damage and the metal springs inside the battery compartment were melted from the heat.This transmitter also had a white lcd screen.The device will be returned for evaluation.This device was not in patient use at the time.

• 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
• MDR Report Key: 9162082
• Report Number: 8030229-2019-00538
• Device Sequence Number: 2430357
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021
• Report Date (Section F): 10/07/2019

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: 09/18/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2019
• Device Age: 46 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/07/2019