Model Number ZM-521PA |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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The biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.This device was not in patient use.
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Manufacturer Narrative
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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.
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Event Description
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The biomedical engineer (bme) reported that the telemetry transmitter had inaccurate ecg readings and was missing information.This device was not in patient use.
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Search Alerts/Recalls
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