Model Number 6004001 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device gave error code e4 and e20.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Date of event is unknown.No information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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B5: additional information received, corrected data: b3, h6 problem patient code.
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Event Description
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Additional information received via email: the event occurred during testing on (b)(6) 2022.There was no patient/clinical injury.
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Manufacturer Narrative
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A review of this file determined it to be not reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File cc-0182278 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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