Model Number GZ-130PA |
Device Problem
Patient Data Problem (3197)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2023 |
Event Type
malfunction
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Event Description
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The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.
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Manufacturer Narrative
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The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.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(s) contain no information (ni), as attempts to obtain the information were made, but not provided: a2: a6.B6: b7.D10: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: (b)(6 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
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Event Description
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The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.
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Manufacturer Narrative
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Incident summary: the biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.Investigation summary: multiple follow-up requests regarding the return of the device were made to the customer, but the customer has been unresponsive to the phone call messages and emails sent for the return of this device.A definitive root cause could not be determined since we have not received the device for evaluation.Possible cause may include hardware component failure due to physical damage or fluid intrusion from user mishandling, electrical damage from improper battery usage, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number does not show other complaints.The complaint could not be confirmed as we have not received the device after multiple follow-up requests.Nk will continue to monitor and trend similar complaints.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/28/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/18/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
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Search Alerts/Recalls
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