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Model Number 2110 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: event date unknown.D3, g1,2 email is: (b)(6).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 information becomes available.
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Event Description
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It was reported that the device rate was not reading properly and needed calibration.It is unknown if there was patient involvement, no adverse patient effects were reported.
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Manufacturer Narrative
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One device was returned for analysis.Visual inspection showed the pump was in good condition.The tamper seal was broken.There was no evidence to review in the device's event history.A functional test was performed and the reported issue was not duplicated.The device functioned as intended.It was determined that the most probable cause was due to a user error.As a result, preventive maintenance was performed.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.D3, g1, and g2 email is: regulatory.Responses@icumed.Com.
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Search Alerts/Recalls
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