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Model Number HEMSGM10 |
Device Problems
No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
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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 08/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Examination of the returned swan ganz module confirmed that while being connected to a data bridge interface test tool, measurements could not be obtained.A fault message ¿oximetry temperature¿ was displayed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically.Svo2 is one indicator of multiple hemodynamic parameters that are used to base clinical treatment decisions.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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.Please see medwatch #2015691-2018-02757 for the hem1 monitor , and medwatch #2015691-2018-02796 for the oximetry cable involved in this event.
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Event Description
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It was reported during use of the swan ganz module, the hemosphere monitor stopped showing cardiac output (co) and cardiac index (ci).The next day, the monitor froze on svo2 measurements with no new values recorded.The clinician attempted to restart continuous cardiac output (cco), which was successful and accurate after rebooting the system.They were unable to perform the oximetry calibration.The monitor was exchanged for a vigilance ii, which worked appropriately with the same swan ganz catheter.There was no report of any patient injury or compromise, and no treatment was given to the patient due to this event.Patient demographics were unable to be obtained.
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Manufacturer Narrative
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A device history record review was completed and documented that device met all specifications upon distribution.Date of manufacture and expiration date corrected to 27-sep-2017and 26-sep-2022, respectively.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference (b)(4).
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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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