Model Number CNS-6801A |
Device Problems
No Display/Image (1183); 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 02/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that one of the monitors is not displaying anything on the central nurse's station (cns).Technical support (ts) had the customer check the physical connections and then power cycle the kvm for the unit.The power seemed to be connected to the display.Ts asked the customer to have their biomed troubleshoot the issue further and possibly look at the closet where the cns is stored.There was no patient injury 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 customer reported that one of the monitors is not displaying anything on the central nurse's station (cns).There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that one of the monitors is not displaying anything on the central nurse's station (cns).Technical support (ts) had the customer check the physical connections and then power cycle the kvm for the unit.The power seemed to be connected to the display.Ts asked the customer to have their biomed troubleshoot the issue further and possibly look at the closet where the cns is stored.There was no patient injury reported.Investigation summary: the nihon kohden (nk) technical support (ts) and quality assurance (qa) team reached out to the customer via email on (b)(6) 2024 and through phone messages on (b)(6) 2024.Despite these attempts, the customer did not respond, and no additional information was provided.Due to the customer's non-responsiveness and the user-dependent nature of the issue, we cannot determine a definitive root cause.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative manufacturer references (b)(4).Follow up 001.
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Event Description
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The customer reported that one of the monitors is not displaying anything on the central nurse's station (cns).There was no patient injury reported.
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Search Alerts/Recalls
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