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

Model Number ZM-540PA

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 207155500
• Report Number: 8030229-2020-00521
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION