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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 b10009704, as a result of warning letter cms# 617147.D4: 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.Device was received in a fair condition.Unit failed to turn on.Removed front cover and investigated further.Found broken power switch and damaged line cord.The root cause of the reported issue was found to be a broken solder joint between power switch and the power control board.Actions were taken to mitigate the reported issue: are unknown.A corrective and preventative action has been opened to address the reported issue.
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Event Description
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It was reported that the warmer had a broken power switch, bad power cord.No patient injury was reported.
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Search Alerts/Recalls
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