Model Number 7209807- |
Device Problem
Melted (1385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during set up, the device was so hot that it melted and came apart.It was sterilized and cleaned.No patient involved.
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Manufacturer Narrative
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Evaluation summary post market vigilance (pmv) led an evaluation of one device.Complaint of motor failure was confirmed.Cause of motor failure is a defective motor/gearbox.Motor is shorted out and damaged electronic components on the main pcb of the test control unit.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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