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Model Number ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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As of this time, has been shipped for investigation.However, the customer confirmed that the sample is available.As an intervention, an ambu bag was required to be used until it was replaced with a new circuit.Any additional information received from the customer will be included in a follow-up report.
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Event Description
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The customer reported that the adu520x4d vital signs adult anesthesia breathing circuit experienced circuit malfunction due to plastic piece covering the air exchange circuit filter during use.The customer confirmed that there was no patient harm associated with this reported event.As an intervention, a manual ventilation was required to be used until it was replaced with a new circuit.
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Manufacturer Narrative
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Result of investigation: one opened sample of the p/n adu520x4d without lot number was received for the investigation.According to investigation, we determined that personnel are related with defect reported, since they did not follow the process to perform change proper the media roll.Also process is related with defect reported, since it is not very clear to perform the change of the roll plush.
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Search Alerts/Recalls
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