Model Number FL28C |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
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.9 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.3 devices are pending evaluation.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 12 malfunction events, where it was reported the devices experienced scale measure weight incorrect.There was no patient involvement.
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Manufacturer Narrative
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3 devices that were pending evaluation were not made available by the customer; the reported issue was not confirmed.One device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Because of this, the number of reported events has been changed from 12 to 11.Section h codes have been updated to reflect this.
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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced scale measure weight incorrect.There was no patient involvement.
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Search Alerts/Recalls
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