SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Catalog Number P310NUS |
Device Problems
Break (1069); Crack (1135); Detachment of Device or Device Component (2907); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the device had overlay damage, a broken alarm pressure knob, and the battery compartment was cracked.The issue was discovered during maintenance; the device was not in use at the time.
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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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Search Alerts/Recalls
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