SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Catalog Number P310NUS |
Device Problems
Break (1069); Failure to Recalibrate (1517)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 unit was broken and out of calibration.It is unknown if the issue was related to physical damage or device abuse.The incident was found during testing.There was no patient involvement.
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Search Alerts/Recalls
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