Catalog Number 8065750833 |
Device Problems
Decrease in Suction (1146); Mechanical Problem (1384); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that the equipment was rejected the cassette during prime, after finished the prime, it presented low efficiency in vacuum during procedure and it turned off totally with no system message.Again turned on the equipment and completed the procedure.Patient harm was not reported.Additional information has been requested.
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Manufacturer Narrative
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The service request (sr) was cancelled.And the customer decided to uninstall the system.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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