Catalog Number CON-HL-90 |
Device Problem
Power Problem (3010)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2021 |
Event Type
malfunction
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Event Description
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Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 malfunctioned.Issue discovered (b)(6) 2021.Staff reported no power and it was confirmed to be an intermittent issue due to the solder joint on the board.
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Manufacturer Narrative
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Device evaluation - the device was returned for evaluation.The device was given functional testing.The device could be successfully powered on with no issues.Investigation determined excessive pump noise occurred but the reported issue was not confirmed.
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Manufacturer Narrative
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This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with in appearance a new enclosure kit.The line cord is worn and the device contains an old style board.The technician plugged in device and powered on.The report issue was not confirmed.Device powered up with the operating indicator lit.The root cause of the reported issue was unable to be determined, problem may be intermittent and was not able to duplicate at the time of evaluation.There were other problems found with a loud pump.No action taken due to the age and condition.Unit was scrapped.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
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Search Alerts/Recalls
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