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Catalog Number 317-09-02 |
Device Problems
Air Leak (1008); Inaccurate Flow Rate (1249); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that the device displayed an air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on the device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected, and then, they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.
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Manufacturer Narrative
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The reported issue (it was reported that the device displayed air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected and the they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.) for this complaint was unconfirmed.According to the test method, flow rate was found to be acceptable on all the returned pads.The flow rate for this product must be above 2.4 l/min m2.The energy connector for the right chest pad was found damaged however, it did not affect the sample returned in any way, it was found to be a cosmetic defect.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿ (b)(4).
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Event Description
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It was reported that the device displayed an air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on the device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected, and then, they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.
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Search Alerts/Recalls
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