Model Number 14-874 |
Device Problems
Material Frayed (1262); Sparking (2595); Unintended Electrical Shock (4018)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Results pending completion of the investigation.H3 other text : although requested, the customer indicated the power-supply was discarded.
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Event Description
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The customer reported observing sparks from their frayed cholestech ldx analyzer power-supply during the performance of a hard reboot.The analyzer had not recently been moved or dropped and the analyzer was set up on a dry, stable surface with no other instruments around.Technical services attempted to gather additional information on the location of the fray and spark on the power supply, however the customer could not provide additional details and indicated the power supply had been discarded.No injury or harm reported.No further information was provided.
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Manufacturer Narrative
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Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Review of the risk documents for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information.Complaints are tracked and trended on a monthly basis.H6 - adverse event problem and h10 - additional mfg narrative were updated as the investigation was completed.H6 - adverse event problem: medical device problem code was previously submitted as "a0714 unintended electrical shock" and should have been submitted as "a0704 sparking" and "a040605 material deformation: material frayed".H3 other text : although requested, the customer indicated the power-supply was discarded.
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Event Description
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The customer reported observing sparks from their frayed cholestech ldx analyzer power-supply during the performance of a hard reboot.The analyzer had not recently been moved or dropped and the analyzer was set up on a dry, stable surface with no other instruments around.Technical services attempted to gather additional information on the location of the fray and spark on the power supply, however the customer could not provide additional details and indicated the power supply had been discarded.No injury or harm reported.No further information was provided.
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Search Alerts/Recalls
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