Model Number 8120 |
Device Problems
Calibration Problem (2890); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii), the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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Event Description
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It was reported that the pca modules come back to biomed shop with a message "need calibration" within a short amount of time.It was reported that their biomed follows the procedure in alaris system maintenance software and use the alaris calibration sets for these devices and yet "they have still been coming back frequently with a "need calibration" message.There was no patient involvement.
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Manufacturer Narrative
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Omit : c20 - no findings available, d15 - cause not established.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
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Event Description
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It was reported that the pca modules come back to biomed shop with a message "need calibration" within a short amount of time.It was reported that their biomed follows the procedure in alaris system maintenance software and use the alaris calibration sets for these devices and yet "they have still been coming back frequently with a "need calibration" message.There was no patient involvement.
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Search Alerts/Recalls
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