Catalog Number 6252000000 |
Device Problem
Device Fell (4014)
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Patient Problems
Abrasion (1689); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device experienced frame unexpected drop/collapse.There was 1 event with patient and 1 user involvement; the patient experienced an abrasion; the user received an unknown minor injury.
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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.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Manufacturer Narrative
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The device that was pending was evaluated in the field but the issue was determined to be a different hazard and was found with a new awareness date, which will be covered in a different vmsr quarter.Because of this, the number of reported events has been changed from 1 to 0.
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Event Description
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This report summarizes 0 malfunction events, where it was reported the device experienced frame unexpected drop/collapse.There was no patient involvement.
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Search Alerts/Recalls
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