SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Catalog Number P310NUS |
Device Problems
Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Other, 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 gauge was not working and the o2 knob was broken.Patient involvement is unknown.
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Event Description
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Additional information received via email.The customer does not know if the item was dropped or not.The problem was found during preventive maintenance.
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Manufacturer Narrative
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Other text: a1, b5, and h6.Health effects: updated.D3, g1,2 email is: (b)(4).
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Search Alerts/Recalls
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