MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-540PA; TRANSMITTER

Model Number	ZM-540PA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the transmitter was not reading ecg leads and there was no error message.The monitoring tech noticed it when they went into full disclosure and only saw a qrs wave on lead 2.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: the central nurse's station was being used in conjunction with the telemetry transmitter, but no model or serial number information was provided.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter was not reading ecg leads and there was no error message.The monitoring tech noticed it when they went into full disclosure and only saw a qrs wave on lead 2.No patient harm reported.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter was not reading ecg leads and there was no error message.The monitoring tech noticed it when they looked at full disclosure and only saw a qrs wave on lead 2.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the zm transmitter was not reading the ecg leads.No error message was given.The monitor technician noticed it when looking at full disclosure and only saw a qrs wave on lead 2.No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) initiated a warranty exchange for the zm device.With the information available, a root cause cannot be determined.Fuzzy or inaccurate waveforms (e.G., sawtooth patterns, square waves) and wave artifacts (signal noise, lead placement, lead connection, network interference) may be caused by faulty lead placement or faulty leads.Users should verify that the leads are authorized for use with the zm transmitter in operation before monitoring a patient.Improper connection of leads (leads not properly seated), and/or damaged or contaminated leads (dirt, dust and/or cleaning residues) may contribute to ecg issues.If the leads are not seated properly to the zm transmitter, readings will not appear properly.

• Brand Name: ZM-540PA
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10519156
• Report Number: 8030229-2020-00521
• Device Sequence Number: 3055145
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/03/2023

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-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2015
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION
• Patient Sex: Unknown