Model Number 21-2111-0300-01 |
Device Problem
Calibration Problem (2890)
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Patient Problems
Insufficient Information (4580); 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: 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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It was reported the device needed calibration for over infusing.No patient injury/involvement reported.
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Manufacturer Narrative
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Other text: one device was received for evaluation.Visual inspection found the device to have a scratched lcd lens, and a bubbled dso seal.There was no evidence to be found in the device's event history log.Three accuracy tests were performed.Upon review, the reported problem was unable to be duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period.G2 email is: regulatory.Responses@icumed.Com.
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Search Alerts/Recalls
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