Model Number HL-90 |
Device Problem
Output Problem (3005)
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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 the device is not in tolerance.Additional information received 04october2022 via email: no patient involvement.
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Manufacturer Narrative
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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 text: additional event information received indicating no patient involvement (updated b5, a1).
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Event Description
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Additional information received on 04october2022 via email and attached to complaint object: no patient involvement was reported.
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Manufacturer Narrative
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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.Service history review identified this device was last in for service in oct 2021 for leaking therefore this complaint is not related to a previous repair.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.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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