Model Number HEMOXSC100 |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The unit is expected to be returned for analysis; however, it has not yet been received.Upon the return of the unit, a supplemental report will be sent with the investigation results.Additionally, a device history record review has been initiated to ensure that the device met all specifications upon distribution and there are no previous service record findings.Udi # (b)(4).
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Event Description
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It was reported that during use there were drifting values noted with the hemosphere oxsc cable.The clinician could perform an initial in-vivo calibration at 64%; however, after 1-3 hours it drifted lower.The clinicians questioned the values because the drift did not correlate to the patient condition or symptoms; therefore, the patient was not treated off of the values on the monitor.There was no patient harm or injury reported.Patient demographics were requested and not provided.
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Manufacturer Narrative
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A hemosphere oximetry cable was received for evaluation.The cable was tested per the system verification testing.It was observed and left to run for 27 hours.The sv02 values were within appropriate parameters.There were no error messages identified.The cable passed the fct3 testing.The device diagnostic log was reviewed and it did not identify any faults or errors that would contribute to the device failure.An external inspection was performed and there was no visible physical damage found.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue of inaccurate values was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the issues; therefore no corrective action was taken.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.In this case it is unknown if user or procedural factors played a part in this event.There was no patient compromise noted in this event.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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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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