Catalog Number 5372 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has been returned to the manufacturer for evaluation, however the evaluation of said device has not been completed at the time of this report.
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Event Description
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Customer complaint reported: "when resuscitation bag was used on patient, health care provider found difficulty with ventilation & exhalation (was able to exhale but it was prolonged).Provider examined the resuscitation set and found that 15 mm connector that attaches to the ett, pushes the duck valve making it difficult to inspire and exhale." no patient harm reported.Patient condition reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned to the manufacturer (galemed) for evaluation.Galemed reports the following: a visual exam was performed and it was observed that the duckbill valve was opened.The returned sample was compared with the normal nrv and it was found that the length of the connector outside the cap of the returned sample was shorter than the normal sample.After applying certain force to the connector of the normal nrv, the same defect phenomenon was simulated.Galemed also reports that at the assembly process, 100% expiratory resistance testing is performed on the products and a defect of this type would be detected prior to release.It was determined this complaint defect happened during the transportation or using due to the large outer force impaction.
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Event Description
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Customer complaint reported: "when resuscitation bag was used on patient, health care provider found difficulty with ventilation & exhalation (was able to exhale but it was prolonged).Provider examined the resuscitation set and found that 15 mm connector that attaches to the ett, pushes the duck valve making it difficult to inspire and exhale." no patient harm reported.Patient condition reported as fine.
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Search Alerts/Recalls
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