Catalog Number 004670010 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2019 |
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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Customer reported the light pipe shroud was sharp and may have lacerated the tissue in a neonatal airway.It was reported the physician assistant had difficulty intubating a patient and some blood was suctioned from the airway.The patient was successfully intubated and no further harm was reported.
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Event Description
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Customer reported the light pipe shroud was sharp and may have lacerated the tissue in a neonatal airway.It was reported the physician asssistant had difficulty intubating a patient and some blood was suctioned from the airway.The patient was successfully intubated and no further harm was reported.
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Manufacturer Narrative
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(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that an inspection for sharpness of the blade (metallic part) was performed but no sharpness on the blade was found.The manufacturer also reports that they inspected the exposed area of the light guide (pipe) on a profile projector and it was found that the radius is as per drawings and no specific sharpness was found.There was a similar issue reported in (b)(6) 2018.At that time all inventory of the light guide (pipe) was reworked to remove sharp edges under a non-conformance.The product supplied under this lot (2j0818) is reworked and free from sharp edges.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The device was found to conform with design specification.
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Search Alerts/Recalls
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