Model Number MR290V |
Device Problems
Air Leak (1008); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint mr290 vented autofeed humidification chamber is expected, but has not yet been returned to fisher & paykel healthcare in (b)(4).We will provide a follow up report upon completion of our investigation.
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Event Description
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A distributor in (b)(4) reported via a fisher & paykel healthcare field representative that the mr290v vented humidification chamber was leaking.This was found before use on a patient.
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Event Description
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A distributor in colombia reported via a fisher & paykel healthcare field representative that the mr290v vented autofeed humidification chamber was leaking.This was found before use on a patient.
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Manufacturer Narrative
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(b)(6).The complaint mr290 autofeed humidification chamber was not returned to fisher & paykel healthcare in new zealand for evaluation.Without examining the complaint device we are unable to confirm a fault with the device.The distributor reported that the subject mr290 chamber has a leak.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails either of these tests is rejected.The chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290 state the following: - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarm.".
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Search Alerts/Recalls
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