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	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter overheated and the temperature feels higher than usual, in the rear of the transmitter, particularly in the battery area where the batteries connect.The transmitter still works and transmits waveforms and vital signs as normal.There is nothing else wrong with it other than it being super warm in the rear, battery area.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 field contains no information (ni), as attempts to obtain information were made, but not provided.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter overheated and the temperature feels higher than usual, in the rear of the transmitter, particularly in the battery area where the batteries connect.The transmitter still works and transmits waveforms and vital signs as normal.There is nothing else wrong with it other than it being super warm in the rear, battery area.No patient harm reported.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter overheated and the temperature feels higher than usual, in the rear of the transmitter, particularly in the battery area where the batteries connect.The transmitter still works and transmits waveforms and vital signs as normal.There is nothing else wrong with it other than it being super warm in the rear, battery area.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the telemetry transmitter, being monitored at the central nurse's station (cns), went into signal loss.When they checked the patient and the transmitter, they found that the transmitter was overheating.They said they were going to return the device for evaluation and exchange but decided to keep the device.No patient harm was reported.Service requested / performed: investigation.Investigation summary: the root cause is determined to be that the transmitter design did not foresee the possibility of a short circuit from incorrect insertion of the battery.An nkc investigation was performed under irc-nka300097945 and concluded that incorrect insertion of the battery may cause the battery terminal springs 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 which would add an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.

• 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
• MDR Report Key: 9470244
• Report Number: 8030229-2019-00720
• Device Sequence Number: 3987446
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/20/2021
• Report Date (Section F): 12/13/2019

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 32 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 08/20/2021
• 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: 12/13/2019