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Catalog Number CON-HL-390 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi information is unknown.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Received device in used condition.Found pins on liquid-crystal display (lcd) bent inward.The root cause of the reported issue was found to be most likely due to customer damage.Actions were taken to mitigate the reported issue: device scrapped due to age and condition.
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Event Description
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It was reported that the warmer had a bad liquid-crystal display(lcd).No patient injury was reported.
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Search Alerts/Recalls
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