SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45091675D-NL |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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B3: date of event; and d4: udi number are unknown, no product information has been provided to date.D4: expiration date and h4: manufacture date are not available based on reported lot numbers.G5: 510k is blank device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported pretesting showed that the circuit failed the gas machine pressure test.A new circuit was put on the gas machine, and it passed the pressure test.Possible lot number: 4341247 or 4364557.
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Manufacturer Narrative
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Other, other text: d10 - device available for evaluation and h6 - evaluation codes: updated device evaluation: twenty unused devices, in their original packaging completely sealed, were returned for investigation.Visual inspection and functional testing found no faults or defects.The complaint could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective action is required as there is no information if the product leaks in the pre-check, which is listed in the instructions for use.
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Search Alerts/Recalls
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