Model Number 60000000 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the arctic sun device was not cooling.A functional check determined it was cooling but was having issues with heating.Mss asked the nurse to drain 500 ml from device and device heated to 40c.Biomed was going to run a calibration and then return the device to service.
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Event Description
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It was reported that the arctic sun device was not cooling.A functional check determined it was cooling but was having issues with heating.Mss asked the nurse to drain 500 ml from device and device heated to 40c.Biomed was going to run a calibration and then return the device to service.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the issue was unconfirmed.The reported event could not be duplicated.A functional check determined it was cooling but was having issues with heating.Mss asked the nurse to drain 500 ml from device and device heated to 40c.Biomed was going to run a calibration and then return the device to service.All good faith attempts have been made to obtain additional information.The outcome of the repair could not be determined at this time.The device history record review and labeling review was not required as the reported event was unconfirmed.H11:section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
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Search Alerts/Recalls
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