Model Number PEDICAP |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670); Human-Device Interface Problem (2949)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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The report did not provide the lot number which determines the date of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic was notified of an event through clinical literature publication regarding an infant with imperforate anus.Report stated the endotracheal intubation was "confirmed" by detection of exhaled carbon dioxide with a pedi-cap (covidien, (b)(4)) and subsequent chest x-ray.Further investigation of the event revealed a false positive of bronchial placement due to patient intubation within the esophagus.Investigation efforts are ongoing regarding the circumstances of the reported event.
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Manufacturer Narrative
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Further investigation of the customer event revealed the product was not a contributory factor in the patient¿s death.A medical safety review of the patient event was completed and determined there is no current long term treatment available for this type of defect and while temporary management may include insertion of an esophageal tube, infants with a complete absence of the trachea tend to die within hours of birth, as a permanent airway cannot be created.The esophageal tube placement assisted in temporarily prolonging the life of the patient, just as mentioned in the mcgill j med.2011 jun; 13(1): 10.Published online 2011 jun., but would not be a permanent solution for survival of the patient.Per the ifu, correct positioning must be verified by clinical assessment and identification of carbon dioxide in the expired gas.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic was notified of an event through clinical literature publication regarding an infant with imperforate anus.Report stated the endotracheal intubation was "confirmed" by detection of exhaled carbon dioxide with a pedi-cap (covidien, (b)(4) and subsequent chest x-ray.Further investigation of the event revealed a false positive of bronchial placement due to patient intubation within the esophagus.
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Search Alerts/Recalls
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