Model Number 6506 |
Device Problem
Device Tipped Over (2589)
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Patient Problems
Abrasion (1689); Bruise/Contusion (1754); Pain (1994)
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Event Date 01/01/2023 |
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; no defects or malfunctions were found.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 3 malfunction events, where it was reported the devices experienced unstable cot leading to tip.There was 3 events with patient involvement; 1 patient experienced a bruise/contusion, 1 patient experienced an abrasion and pain, and 1 patient experienced an abrasion.
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Manufacturer Narrative
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The device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Section h codes have been updated.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the devices experienced unstable cot leading to tip.There was 3 events with patient involvement; 1 patient experienced a bruise/contusion, 1 patient experienced an abrasion and pain, and 1 patient experienced an abrasion.
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Search Alerts/Recalls
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