MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS
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Catalog Number 317-09-02 |
Device Problems
Component Missing (2306); Component Misassembled (4004)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that the customer received a defective pad shipment, two sets of pads contained 2 left chest and 2 left thigh pads.
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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.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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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be ¿operator error ¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labeling could not have prevented the reported failure.Correction: a,b,f, 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 the customer received a defective pad shipment, two sets of pads contained 2 left chest and 2 left thigh pads.
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Search Alerts/Recalls
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