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Catalog 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 06/03/2019 |
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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It was reported by the customer via phone that the fms vue pump had no suction.The pump was moving but it was not giving any suction.They were able to complete the case with another like device with no patient harm or surgical delay to the case.
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Manufacturer Narrative
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Product complaint #: (b)(4).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 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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Manufacturer Narrative
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Product complaint # (b)(4).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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated at the service center.Per service manual operational and diagnostic analysis does not confirm the reported issue (pump was moving but it wasn't giving any suction).However, the repair and testing of the unit was not completed at the time because there was no need for it in the equipment loaner pool due to excess units in the pool at the time.The device was placed into long term hold.Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined.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 03/09/2016 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.Depuy 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.Udi: (b)(4).
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Search Alerts/Recalls
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