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Catalog Number 1041 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been received for evaluation by the manufacturer at the time of this report.However , material from the production line was verified and no issues were found that can lead this customer complaint.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 in this complaint.Customer complaint cannot be confirmed based only on the information provided.Root cause is unknown.No corrective actions can be assigned.If the sample becomes available this investigation will be updated with the evaluation results.
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Event Description
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Customer complaint alleges that during use on a patient, the tubing is loose and comes disconnected from the mask.No patient injury or complication was reported.Patient condition reported as "fine".
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Search Alerts/Recalls
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