Catalog Number 4100231000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).2 events were reported for this quarter.1 device was available for evaluation but has not yet been received.1 device was received for evaluation.1 device was affected by separated components.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 2 malfunction events in which the device disassembled.2 events had no patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number e2015055.1 previously reported event is included in this follow-up record.Product return status: 1 device was available for evaluation but has not yet been received.1 device is not labeled for single-use.1 device was not reprocessed and reused.
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Event Description
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This report summarizes 2 malfunction events in which the device disassembled.2 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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