Catalog Number 6252000000 |
Device Problem
Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was evaluated in the field and the issue was confirmed; the device had broken/damaged components.The devices were repaired and returned.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 3 malfunction event(s), where it was reported the device collapsed or dropped.There was patient involvement, however there were no consequences or impacts to the patient.
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Manufacturer Narrative
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This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.It was originally reported 1 device was evaluated in the field; however, 2 devices were evaluated in the field and the issue was confirmed; the device had broken/damaged components.The devices were repaired and returned.The remaining device was not evaluated as the customer did not make the device available for testing.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 3 malfunction event(s), where it was reported the device collapsed or dropped.There was patient involvement, however there were no consequences or impacts to the patient.
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Search Alerts/Recalls
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