Model Number 8015 |
Device Problems
Loose or Intermittent Connection (1371); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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Event Description
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It was reported by the customer that the pcu batteries are not secured properly.There was no patient involvement.
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Event Description
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It was reported by the customer that the pcu batteries are not secured properly.There was no patient involvement.
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Manufacturer Narrative
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Omit: c20 - no findings available.Correction : if other specify.Additional information : imdrf annex a, b, c codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : customer provided sample photo only.No device was returned.
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Search Alerts/Recalls
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