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Model Number IPN915504 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: "during intubation, the light went out.We always have access to regular blades mac 4.In this case, the blades were changed." no patient injury, harm, or consequence reported.Patient condition reported as "doing well." associated mdr 3011137372-2022-00200.
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Manufacturer Narrative
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(b)(4).The customer returned one 4150130 rusch polaris fo blade mac 3 for investigation.Visual examination did not reveal any obvious defects or anomalies.The device appeared typical.Functional inspection was performed by attaching the blade to a known good rusch dispoled lab inventory handle.To switch on, the blade was pulled up and the blade was able to properly illuminate.Then a load was applied to the blade and handle using a weight scale as the customer complaint stated that the light did not illuminate once force was applied to it.The blade was applied a continuous force of up to approximately 6lbs and the light did not turn off at any point.There were no visual signs of any light deficiency within the blade.This testing was performed with an additional lab inventory handle to confirm the results.Testing with the second lab inventory handle also revealed proper light function of the returned blade.The manufacturing dhr file was reviewed based on the lot reported.No recorded results of manufacturing issues or anomalies were reported.The complaint cannot be confirmed.Functional testing confirmed that the blade was able to properly illuminate with multiple lab inventory handles attached.The returned blade was put under an applied load
and the light did not turn off at any point.No issues were identified with the light function of the blade.A device history record review was performed with no relevant findings identified.Therefore, the complaint cannot be confirmed as there was no fault found with the device.Teleflex will continue to monitor and trend on complaints of this nature.
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Event Description
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It was reported that: "during intubation, the light went out.We always have access to regular blades mac 4.In this case, the blades were changed." no patient injury, harm, or consequence reported.Patient condition reported as "doing well." associated mdr 3011137372-2022-00200.
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Search Alerts/Recalls
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