Model Number 7126-120-000 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 8 events were reported for this quarter.Product return status: 1 device was received.1 device was not available for evaluation.6 device investigation types have not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by a swollen o-ring.8 devices were not labeled for single-use.8 devices were not reprocessed or reused.
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Event Description
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This report summarizes 8 malfunction events in which the device was reportedly difficult to open or close.8 events had patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 8 previously reported events are included in this follow-up record.Product return status 7 devices were received.1 device was not available for evaluation.Event confirmation status 7 reported events were confirmed.Evaluation results 1 device was found to be affected by a swollen o-ring.3 devices were found to be affected by a manufacturing deficiency.3 devices were found to be affected by loose contact terminal locks.
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Event Description
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This report summarizes 8 malfunction events in which the device was reportedly difficult to open or close.8 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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