Model Number 2110 |
Device Problems
Insufficient Flow or Under Infusion (2182); Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/01/2023 |
Event Type
malfunction
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Event Description
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It was reported the patient was on a continuous pca hydromorphone drip post-surgery.The device alarmed low battery.The device was then plugged in but it would not charge.After five minutes the device wouldn't hold a charge.This resulted in patient not receiving continuous iv pain medication for 30 minutes.It was reported the patient was alert and oriented, the bedside registered nurse monitored for signs of increased pain.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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Other, other text: 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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No product was returned.The investigation determined the most probable cause to be the depleted internal battery, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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