VYAIRE MEDICAL AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML.; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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Model Number HUMIDIFIER KIT 500ML 12/CS |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Also, the issue happened with three lot numbers.Please see (b)(4).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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It was reported to vyaire medical that during use, the hospital staff noticed that the (b)(6) - humidifier kit 500ml 12/cs was easily disengaged from the oxygen gauge.They also observed that it constantly alarms, and the pressure is building up inside the bottle, which causes it to expand or bloat.Upon inspection, they noticed that the oxygen port opening was too small.The customer confirmed that there was no patient harm associated with the reported event.
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Manufacturer Narrative
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Additional information: g3, g6, h2, h3, h6 and h10.The origin of the finding that generates the low yield affectation in lot tl2205041 is attributed to the increase in rejections due to the covered pivot in the conditioning stage.This increase has a multifactorial root cause: "equipment." since there were constant stoppages due to malformation, despite the fact that this defect is easy to segregate due to its visual evidence, there is a possibility that some parts were sterilized with the "covered pivot" defect because the backpressure test is performed every 2 hours according to what is established in the bmr.That is why it is also attributed to the "method," since there is no reference to the frequency of the backpressure test when the equipment presents failures due to malformation.Based on the above, the non-functional parts were discarded from the process and classified as nonconforming products.The physicochemical and microbiological results of the parts in good condition comply satisfactorily with the established specifications.
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