Model Number PXVP2284AT3 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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Event Description
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It was reported that a truwave vamp had silicone overspray.Issue was noticed prior to use.No patient injuries reported.
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Manufacturer Narrative
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No engineering evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.Reviews of the device history record, lot history and manufacturing mitigations revealed no indication that a manufacturing nonconformance contributed to the reported complaint.As such, based on available information, a definite root cause is unable to be determined at this time.Corrections to the h6 codes investigation findings and investigation conclusions were made.
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Manufacturer Narrative
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The device was not returned for evaluation.It was previously reported that the device was available for return, but it was discarded.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A supplemental report for the device history record will be forthcoming when the investigation is completed.Corrections to the h6 codes type of investigations were made.
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Search Alerts/Recalls
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