Model Number ORG-9100A |
Device Problems
Device Inoperable (1663); Defective Component (2292); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the org has a noisy ecg and respiration signal.Receiver 1, 5, and 7 are bad.A loaner org was shipped to the customer however did not function correctly.When customer tried to install the loaner org they experienced communication loss issues.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 customer reported that the org has a noisy ecg and respiration signal.Receiver 1, 5, and 7 are bad.A loaner org was shipped to the customer; however, the device did not function properly.When customer tried to install the loaner org they experienced communication loss issues.
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Manufacturer Narrative
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Manufacturer narrative: the customer reported that the org has a noisy ecg and respiration signal.Receiver 1, 5, and 7 are bad.A loaner org was shipped to the customer however did not function correctly.When customer tried to install the loaner org they experienced communication loss issues.The device has been returned to nka, however, the device was misplaced and never evaluated.Device seems to be misconfigured.Due to the age of this complaint additional information necessary to conduct an investigation is not readily available.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.Device not evaluated.
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Search Alerts/Recalls
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