Catalog Number UNKNOWN |
Device Problem
Misassembly by Users (3133)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the nurse called biomed for an alert 001 (patient line open) and an alert 002 (low flow).Ms&s gave them troubleshooting steps.The biomed stated that nurse changed the (b)(6) device and they had the same alert on the new (b)(6) device.Told the nurse to change the (b)(6) gel pads and would call back if that did not help.Per follow up via biomed (b)(6) on 28jan2021, they swapped the original device back in.The actual issue was user error.They connected the pads to the hose incorrectly.They were using the wrong two ports.So when they finally got the pads to connect correctly, therapy was continued.Both devices are currently in service.The user was not with the device so they did not have the serial number.
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Event Description
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It was reported that the nurse called biomed for an alert 001 (patient line open) and an alert 002 (low flow).Ms&s gave them troubleshooting steps.The biomed stated that nurse changed the arctic sun device and they had the same alert on the new arctic sun device.Told the nurse to change the arctic gel pads and would call back if that did not help.Per follow up via biomed john on 28jan2021, they swapped the original device back in.The actual issue was user error.They connected the pads to the hose incorrectly.They were using the wrong two ports.So when they finally got the pads to connect correctly, therapy was continued.Both devices are currently in service.The user was not with the device so they did not have the serial number.
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Manufacturer Narrative
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The reported event was confirmed use related as the flow rate issue is solved by disconnecting and reconnecting the arctic gel pads.It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.No sample was returned for evaluation.The failure mode is use-related, specifically 'air leakage into the system' with a root cause of "misconnection of supply and return lines." the dhr review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.The device was not returned.
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Search Alerts/Recalls
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