Catalog Number 1042 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.The device history record of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.To perform a proper investigation, and determine the source of alleged defect reported, it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed.Root cause is unknown.No corrective actions can be assigned.If the device sample becomes available this report will be updated with the evaluation results.
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Event Description
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Customer complaint alleges the device "tubing is coming apart at the mask connection".Alleged issue reported occurred during use.No patient injury or consequence reported.Patient condition reported as "fine".
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Event Description
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Customer complaint alleges the device "tubing is coming apart at the mask connection".Alleged issue reported occurred during use.No patient injury or consequence reported.Patient condition reported as "fine".
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the female adaptor is easily disconnected from the grommet.The female adaptor tubing was measured and was found to be within dimensional specifications.Based on the investigation performed the complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to assure this issue was originated during the manufacturing process.A dimensional inspection was performed and no dimensional issues were found.However due to customer complaint trending a capa request was initiated in order to further investigate this issue.
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Search Alerts/Recalls
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