SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Catalog Number P310NUS |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
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 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 repair was needed for a broken "exh gas port." the customer stated that there was no patient involvement.
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Manufacturer Narrative
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No product was returned.The investigation was unable to determine the most probable cause as the device was not returned for evaluation.If the product is returned this complaint will be reopened for further investigation.Service history review identified the complaint was not related to a previous service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).
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Search Alerts/Recalls
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