Model Number 8300 |
Device Problems
No Audible Prompt/Feedback (2282); No Apparent Adverse Event (3189)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that since the 12.1.2 upgrade the etco2 modules can be removed or fall below breaths per minute threshold without triggering the patient controlled analgesia pump module pause protocol.There was no information on patient involvement and impact.
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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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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 since the 12.1.2 upgrade the etco2 modules can be removed or fall below breaths per minute threshold without triggering the patient controlled analgesia pump module pause protocol.There was no information on patient involvement and impact.
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Search Alerts/Recalls
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