Model Number 68-1132 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019); Suction Failure (4039)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
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Event Description
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Nurse reported that the catalyst device was not providing suction.The foam dressing was not drawn down completely, and the device was not alarming.No injury was reported.No further information was provided.The event date is unknown.
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Manufacturer Narrative
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Supplemental report is being filed following the submission of the initial mdr report that was submitted on 6/24/2022 due to the investigation findings are available.Device released from qa to stock on 10/12/2018.No service reports were available at the time of this review.Job router was reviewed without issue.Device serial #(b)(6) passed all quality control tests.A sample was received for evaluation.Device unit was inspected and tested visually and functionally and it was confirmed the root cause was due to device had a defective pump which caused no suction and lack of alarm on the device.Device to be serviced and pump to be replaced with quality control team providing management of inspection.
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Search Alerts/Recalls
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