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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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Manufacturer Narrative
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Other, other text: b3: 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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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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Event Description
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Additional information was received via email in response to a request for additional information.The customer stated that "the issue has been resolved for the time being".
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Manufacturer Narrative
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Other, other text: b5 and h6.Evaluation codes: updated.No product was returned, and no photographic evidence was provided to aid in this investigation.As a result, a complaint investigation, product evaluation and problem confirmation cannot be performed.The exact cause could not be determined; however, based on the reported problem, the most probable cause was a cracked tank cover.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.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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