SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX MANUAL RESUSCITATOR; CIRCULATOR, BREATHING-CIRCUIT
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Catalog Number 670003 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: month and year of event have been provided; day is unknown.D4: lot number, expiration date, udi number and h4: device manufacture date are unknown, no information has been provided to date.G5: no 510k as this catalog number is not sold in us.H3: other; device not returned to manufacturer.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 that during a pre-use check, there were multiple broken or nearly broken items in the anesthetic bag.Discontinued use and used another one.No patient injury or clinical affects was reported.
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Manufacturer Narrative
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D9: date returned to mfg.: 11/9/2024.Twelve samples were received without the original package.Per visual inspection, it was possible to detect damage in the twelve breathing bags.The complaint was confirmed.Based on the analysis conducted in the samples provided, the breathing bags present damage, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review could not be performed as the lot number was unknown.The complaint fault has been escalated to address a full root cause investigation.
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Search Alerts/Recalls
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