Model Number BC161-10 |
Device Problems
Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Ps340844.The complaint (b)(4) bubble cpap system is currently en route to fisher & paykel healthcare (b)(6) for evaluation.We will provide a follow up report upon completion of investigation.
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Event Description
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A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.
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Manufacturer Narrative
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(b)(4).Method: the complaint bc161-10 bubble cpap system respiratory tubings were not returned to fisher & paykel healthcare in new zealand for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Conclusion: without the complaint device we are unable to confirm and determine the cause of the reported event.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected.This suggests that any damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions the accompany the flexitrunk infant nasal tubing state: "use caution when positioning the infant interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.
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Event Description
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A healthcare facility in texas reported via a fisher & paykel healthacre (f&p) field representative that the tubing of two bc161-10 bubble cpap system was found to be leaking.There was no reported patient consequence.
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Search Alerts/Recalls
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