Model Number ORG-9110A |
Device Problems
Communication or Transmission Problem (2896); Output Problem (3005)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple transmitters were used in conjunction with the org , but are not the device that experienced failure.Attempts to obtain the following information were made, but not provided: transmitters: model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.
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Event Description
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The customer reported that their multiple patient receiver (org) is intermittently dropping its signal for multiple transmitters that are attached to it.
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Manufacturer Narrative
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Details of complaint: the customer reported that their multiple patient receiver (org) was intermittently dropping its signal for multiple transmitters that were attached to it while monitoring patients.No patient harm reported.Service requested / performed: troubleshooting.Investigation summary: the device was not returned to nk for evaluation and no logs were provided.Since there was not enough information provided by the customer, no root cause could be determined for this incident.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003.Since the root cause was unable to be determined, no capa is initiated.Without a root cause, the counter measure to prevent recurrence cannot be performed.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with model #: ni.Serial #: ni.Transmitters: model #: ni.Serial #: ni.
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Event Description
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The customer reported that their multiple patient receiver (org) was intermittently dropping its signal for multiple transmitters that were attached to it.
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Search Alerts/Recalls
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