Catalog Number 650705550001 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
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.14 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is 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 15 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or false engagement of wagon handle in the upright or horizontal position.There was 1 event with patient involvement; no adverse consequences were reported.
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Manufacturer Narrative
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The device pending evaluation 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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Event Description
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This report summarizes 15 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or false engagement of wagon handle in the upright or horizontal position.There was 1 event with patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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