Model Number HL-90 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that there is leaking from the bottom and the case cracked.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Udi is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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Other, other text: additional event information received (updated b5) h6: event problem and evaluation codes: update not required.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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Additional information received via email 8-dec-2022: issue noticed during testing.Date unknown.
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Manufacturer Narrative
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Other, other text: h6: event problem and evaluation codes: updated.H10: manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found corroded reservoir and drain fitting.Faded front cover and line cord.Cracked tank cover.Outdated printed circuit board (pcb) and power switch.Functional testing found the device is leaking from cracks in the bottom of the tank cover.The root cause of the reported issue was found to be customer overtightened the screws cracking the tank cover.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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