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

Model Number	ZM-521PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.They tried changing the batteries and the leads, but the issue persisted.The transmitter 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.The following field contain no information (ni) for the concomitant medical device: d10.Attempt #1: 05/18/2023 emailed bme for the concomitant medical device: no reply was received.Attempt # 2: 05/24/2023 emailed bme for the concomitant medical device: no reply was received.Attempt # 3: 05/30/2023 emailed bme for the concomitant medical device: response was received "unknown.".Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: na.Org: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.This device was not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.They tried changing the batteries and the leads, but the issue persisted.The transmitter was not in patient use.Investigation summary: evaluation of the returned device was able to confirm that the device was experiencing intermittent signal loss.Fluid intrusion was observed inside of the device and it was missing the battery cover.The initial report of missing and incorrect data was not observed.Due to the fluid intrusion, it is likely that the hardware was damaged, and it is likely the cause of the signal loss and reported data issues.Fluid intrusion would be a result of use error as transmitters are not waterproof devices.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.This 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17125729
• Report Number: 8030229-2023-03588
• Device Sequence Number: 6448926
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/12/2023

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: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS; CNS; ORG; ORG
• Patient Sex: Unknown