Model Number HME NEONATAL 50/CS |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2023 |
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.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
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Event Description
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It was reported to vyaire medical that 5704eu hme filters have condensation inside the bags and was used on a patient.Furthermore, the customer confirmed no harm was done to the patient.
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Manufacturer Narrative
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Result of investigation: based on the investigation and per one picture sent by the costumer of fg 5704eu we cannot confirm the reported defect since the ifu (instruction for use) states the following: ''due to the hch's high efficiency, you may see condensate in the polybag.This is normal occurrence due to the high efficiency of the hch product.'' this means that condensation inside the bag or the presence of water droplets is expected in this product.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Manufacturer Narrative
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Result of investigation: device history record for fg 5704eu with lot number 0004229546 and was reviewed and no issues were found.Based on the investigation and per one closed physical sample sent by the costumer of fg 5704eu with lot number 0004229546 we cannot confirm the reported defect since the ifu (instruction for use) states the following: ''due to the hch's high efficiency, you may see condensate in the polybag.This is normal occurrence due to the high efficiency of the hch product.'' this means that condensation inside the bag or the presence of water droplets is expected in this product and does not compromise the functionality of the product.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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