Catalog Number 385-60 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn #: (b)(4).
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Event Description
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It was reported, "the patient was on a drager in aprv mode.The therapist heard a sound, and found that they column was leaking and the top had separated from the column." no reports of medical intervention required.Patient reported as fine.
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Manufacturer Narrative
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Qn# (b)(4).The customer returned one 385-60 column for investigation.Upon receipt the column was visually inspected for outward, visible signs of misuse/abuse/neglect.The plastic cap of the column was completely separated from the column body.It was determined that the likely root cause for the damaged observed on the column was undue force.The cracks in the top cap indicate that it encountered some trauma.It is likely that the column got stuck in a heater and was forcefully removed causing the cap to separate.The medication on the exterior of the column also suggests that medication leaked down into the column, further suggesting misuse of the device.The complaint has been confirmed.The investigation revealed a damaged column.The root cause for the failure is user error.The plastic of the column can become cracked when encountering undue force.Undue force can occur if the device is hit against a rigid surface.
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Event Description
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It was reported "the patient was on a drager in aprv mode.The therapist heard a sound and found that they column was leaking and the top had separated from the column".No reports of medical intervention required.Patient reported as fine.
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Search Alerts/Recalls
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