Model Number 50000000 |
Device Problem
No Display/Image (1183)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/26/2023 |
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 customer had now decided that they would like the arctic sun device repaired.Per biomed call to mis on (b)(6) 2023, biomed needed assistance with device that turns on, but no power to screen or blank screen.Device just returned from service department.Per follow up information received via phone on 01feb2023, biomed stated that the device was coming in for repair.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
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Event Description
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It was reported that customer had now decided that they would like the arctic sun device repaired.Per biomed call to mis on 26jan2023, biomed needed assistance with device that turns on, but no power to screen or blank screen.Device just returned from service department.Per follow up information received via phone on 01feb2023, biomed stated that the device was coming in for repair.
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Search Alerts/Recalls
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