Model Number ZM-530PA |
Device Problems
Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.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 fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: 02/14/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from the biomedical engineer who stated he was unable to document patient information.He did not provide the model number or serial number of the cns in the concomitant medical device in section d10.
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Event Description
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The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.
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Manufacturer Narrative
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The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.Evaluation/investigation results: evaluation of the returned device was able to duplicate the reported issue of ecg artifacts.Battery contact corrosion and fluid intrusion were observed on the zm transmitter.Fluid can damage electronics through several mechanisms.The root cause was found to be fluid intrusion due to mishandling by the customer.D10 attempt # 1: 02/14/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from the biomedical engineer who stated he was unable to document patient information.He did not provide the model number or serial number of the cns in the concomitant medical device in section d10.Additional manufacturer narrative: b4 date of this report d9 is this device available for evaluation? g3 date received by manufacturer g6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h6 event problem codes.
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Event Description
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The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.
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Search Alerts/Recalls
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