Model Number ZM-531PA |
Device Problems
Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was 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.
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Event Description
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The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.
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Manufacturer Narrative
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Complaint report: the biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.Investigation summary: the reported issue was duplicated and confirmed.Upon evaluation from the repair center, the unit was tested with new batteries, connected to a simulator and the device displayed artifacts and intermittent signal loss.Repair center stated the main board was defective and the device would be scrapped.This unit has expired the warranty period.A serial number review of the reported device (zm-531pa, serial number (b)(6) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/18/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/02/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/08/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.G3 date received by manufacturer on initial medwatch, date that initial report was received by manufacturer was 8-jan-2024.
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Event Description
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The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.
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Event Description
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The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.
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Manufacturer Narrative
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Complaint report: the biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.Investigation summary: the reported issue was duplicated and confirmed.Upon evaluation from the repair center, the unit was tested with new batteries, connected to a simulator and the device displayed artifacts and intermittent signal loss.Repair center stated the main board was defective and the device would be scrapped.This unit has expired the warranty period.A serial number review of the reported device (zm-531pa, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Additional information: b4 date of this report.G3 date received by manufacturer.G3 date received by manufacturer on initial medwatch, date that initial report was received by manufacturer was 8-jan-2024.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
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Search Alerts/Recalls
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