Catalog Number 45372 |
Device Problems
Collapse (1099); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.
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Event Description
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Customer complaint alleges "when using the insufflator, the valve remained "collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
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Manufacturer Narrative
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(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was not returned; however, the customer provided a photo for evaluation.The photo was reviewed and this issue would be detected at the connector assembly and inspection process at the manufacturing facility.The complaint could not be confirmed as the sample was not returned for evaluation.If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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Customer complaint alleges "when using the insufflator, the valve remained "collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
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Search Alerts/Recalls
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