Model Number HL-90 |
Device Problems
Break (1069); 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 was leakage of warming solution from the reservoir tank.The corners of reservoir were breaking.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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Date of event is unknown, no information has been provided to date.G5 is blank, no 510k as product not sold in us.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Event Description
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Additional information was received: the email stated that "the issue has been resolved for the time being".
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Manufacturer Narrative
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Other text: additional information: b5.H6 - evaluation codes: updated device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The exact cause could not be determined; however, based on the reported problem, the most probable cause is a cracked tank cover.If the product is returned, the manufacturer will reopen this complaint for further investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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