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Model Number 01-0043 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Information (3190)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This product is not sold in us and is 510(k) exempt.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 a procedure, the unit had false positive detection.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: one device was received for evaluation.The returned sample met specification as received.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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