Model Number PLATINIUM 4LV SONR CRT-D 1844 |
Device Problem
Packaging Problem (3007)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, it was noted that the box of the subject device had a brown stain.It seems that a liquid was in contact with the box.No damaged external box was reported on delivery, however this was not possible to confirm visually.
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Manufacturer Narrative
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Review of the device history records showed that the cause of the reported issue is related with transportation.
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Event Description
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Reportedly, it was noted that the box of the subject device had a brown stain.It seems that a liquid was in contact with the box.No damaged external box was reported on delivery, however this was not possible to confirm visually.
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Manufacturer Narrative
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Please refer to the attached analysis report.H6 (method) updated.
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Event Description
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Reportedly, it was noted that the box of the subject device had a brown stain.It seems that a liquid was in contact with the box.No damaged external box was reported on delivery, however this was not possible to confirm visually.
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Search Alerts/Recalls
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