Model Number HEM1 |
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 07/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been requested to be returned but has not yet arrived.When the product evaluation results are available a supplemental report will be submitted.The serial number of the device is unknown.When the serial number is available, the device history record review will be completed and the results will be submitted in a supplemental report.
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Event Description
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It was reported that the hemosphere instrument, hem1 monitor, was being used during patient monitoring when the sv values were found to not be working.The cables used were exchanged and that did not help.They secured all connections, but that still did not resolve the issue.There was a balloon pump being used and the clinician stated that when it is used this "affects the numbers".It is unknown how the numbers are affected.The facility has been contacted several times and has been asked for additional details, but there has been no response.The clinicians have said that the co and ci and heart rate numbers were within acceptable range.The facility has since been given instructions on how to set up the equipment and instructed on which cable should be inserted into which port.There was no inappropriate patient treatment administered.The patient demographics were not provided.There is no patient harm or injury.
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Manufacturer Narrative
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This is a correction to note that upon further information obtained about this event, the complaint is no longer reportable.An edwards engineer spoke with a clinician at the hospital.Upon gathering further information it was found that the clinician did not understand the heart rate output he could receive given the way the hemosphere system was set up.The edwards engineer gave further instructions on set up of the system given the clinician's expectations.There was no malfunction of the hemosphere system and no harm or injury to the patient.
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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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