SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Catalog Number P310NUS |
Device Problems
Gas Output Problem (1266); Tidal Volume Fluctuations (1634)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: date of event is unknown, no information has been provided to date.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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Event Description
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It was reported that the device "failed oxygen".Patient involvement is unknown.
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Manufacturer Narrative
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Other text: b3, b5 and h6.Health effects codes, updated.D3, g1,2 email is: (b)(4).
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Event Description
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Additional information received via email.Event date was updated from unknown to 01-august-2023.There was no patient injury and no medical intervention.
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Search Alerts/Recalls
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