Model Number 3005 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.
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Manufacturer Narrative
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The device that originally was reported as not being available for testing was was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
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Search Alerts/Recalls
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