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Model Number 284002 |
Device Problem
Suction Failure (4039)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
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Event Description
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As reported by the customer via phone that the suction is not working on the fms vue pump.They used another like device to complete the case with no surgical delay and no patient consequence.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device was received at the service center and evaluated.The customer reported an issue of the suction was not working on the device.Per service manual operational and diagnostic, this complaint can be confirmed.During evaluation, the inner tubing was found to be liquid filled.The liquid/debris was removed to resolve the issue.After repair, the device was found to be working according to the specifications.When the inner tubing is liquid filled, the suction would not happen as expected, therefore is the root cause of the reported problem.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 06/18/2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot = > the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 06/18/2018 and passed all functional testing before being returned to the customer.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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