Model Number ORG-9100A |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer later found out that the uninterruptible power supply (ups) in the org closet was off.Once the ups was power back up, the org came back up.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 showed signal loss after a power "flicker" at the hospital.There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that the org showed signal loss after a power "flicker" at the hospital.The customer later found out that the uninterruptible power supply (ups) in the org closet was off.Once the ups was power back up, the org came back up.There was no patient injury reported.Investigation summary: the customer reported that the issue occurred after a power interruption at the facility.The customer found that the uninterruptable power supply (ups) had been turned off after the power loss event.After turning the ups back on, the signal loss cleared.As such, the root cause of signal loss is power loss due to third-party device.The risk for patient harm is mitigated in the design of the central monitoring stations as they are designed to notify clinicians in the case that signal occurs with org devices.As signal loss is easily noticeable to clinicians, alternate patient monitoring arrangements can be made in response to signal loss events.There is no evidence of an nk device malfunction.A capa is not warranted.Attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Manufacturer references # (b)(4).
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Event Description
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The customer reported that the org showed signal loss after a power "flicker" at the hospital.There was no patient injury reported.
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Search Alerts/Recalls
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