Model Number HEMPSC100 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been requested for return and the evaluation is anticipated.The complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.The device history record review is pending and the results will be submitted in a supplemental report when available.
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Event Description
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It was reported that there were inaccurate blood pressure readings during patient use.The psc100 pressure cable was connected to the hemosphere monitor.The reading on the hemosphere monitor that was sent to the phillips monitor did not match.The nurse noticed the difference immediately.There were no error messages displayed.The displayed numbers and what they were expected to be are unknown.A new cable was exchanged for the suspect cable and it was connected and it resolved the issue.There is no patient injury.There was no inappropriate patient treatment administered.The patient demographics were requested and were not provided.
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Manufacturer Narrative
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The hemosphere pressure cable was received for product evaluation.The cable was connected to a known good working hemosphere unit for testing.It was tested three separate times and each time it was recognized by the hemosphere without any error messages that displayed.When the cable was connected to a plum simulator, a waveform displayed and was able to be zeroed three times without any issues.A normal mean arterial pressure reading was obtained each time.The cable was moved around during testing and it had no effect on the reading.A visual inspection of the cable found no physical damage.The reported issue was not confirmed.The device history record review was completed and all manufacturing inspections passed with no non-conformances.There was no evidence of a manufacturing non-conformance.It is not known if any procedural factors may have contributed to the 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 part of the monthly review.
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Search Alerts/Recalls
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