Model Number VYNTUS BODY PC |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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Vyaire medical file identification:(b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
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Event Description
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It was reported to vyaire medical that the door completely shattered during installation which resulted to small cuts on the arms, hands, and scalp of the field service representative.There was no patient involved as the event happened during installation.
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Search Alerts/Recalls
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