Catalog Number 5372 |
Device Problems
Inflation Problem (1310); Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is unclear if the device is available for evaluation.Teleflex has requested the device.
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Event Description
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Report received via medwatch (uf/importer # (b)(4)) states: ambu mask was not inflated coming out of the package during cardiac arrest/cpr event.There was no report of patient harm.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Report received via medwatch (uf/importer #: (b)(4)) states: ambu mask was not inflated coming out of the package during cardiac arrest/cpr event.There was no report of patient harm.
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Search Alerts/Recalls
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