Model Number HEM1 |
Device Problems
Computer Software Problem (1112); Operating System Version or Upgrade Problem (2997)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The unit has not been received for evaluation.Once received and any evaluation results that are available will be submitted in a supplemental report.The device service history record review is pending.When the results are available they will be submitted in a supplemental report.The other mdr submission numbers for the other 4 units involved will be submitted when available.
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Event Description
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It was reported that the hemosphere hem1 unit arrived at the facility with the incorrect software version.The facility had requested an overnight shipment of the units to use for surgery.When it arrived with the incorrect software it was not able to be used.The surgery was postponed.There were five hem1 units that arrived with the incorrect software version.There was no patient injury, but the surgery was postponed.
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Manufacturer Narrative
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The unit has not been received for evaluation.The evaluation results will be submitted in a separate follow up submission when available.The device history service record review was completed and all manufacturing inspections passed with no non-conformances.The other units involved have been reported with the following id submission numbers; 2015691-2022-04509, 2015691-2022-04510, 2015691-2022-04511, 2015691-2022-04512, 2015691-2022-04513.
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Manufacturer Narrative
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The hemosphere instrument was returned for evaluation.The current software version was installed; however, it matched the original build software, shm 1.0.0.28, dbm 01.00.021.There was no physical damage found.There was no defect found with the unit.
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Search Alerts/Recalls
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