VYAIRE MEDICAL INFANT FLOW LP HEADGEAR, EXTRA SMALL; VENTILATOR, CONTINUOUS, FACILITY USE
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Model Number INFANT FLOW LP HEADGEAR, EXTRA SMALL |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Pressure Sores (2326)
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Event Date 10/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet, since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that the patient was discovered to have a purplish spot on the forehead after using the infant flow lp headgear the entire night.The wound was sutured and applied ointment, and the baby was put on oxygen cannulae.However, the customer and end user both agreed that this is a case of device misuse as 3-hour checks of the device had not been done as indicated by the manufacturer and by the department protocol.
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Manufacturer Narrative
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The suspect device was not returned for evaluation and the device history record could not be obtained using the lot number 62396459.Therefore, no root cause has been determined.
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Search Alerts/Recalls
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