Model Number N/A |
Device Problems
Failure to Pump (1502); Unclear Information (4052)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that once the device was linked to the vacuum, it was not possible to obtain a negative pressure.
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Manufacturer Narrative
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(b)(4).The device will not returned to the manufacturer.Therefore it could not be analyzed the device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause of the event cannot be determined following the investigation results of this complaint, no corrective action has been performed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It has been reported that once the device was linked to the vacuum, it was not possible to obtain a negative pressure.
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Search Alerts/Recalls
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