Model Number PX260 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Follow-up is ongoing for device availability.The complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.
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Event Description
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It was reported that during use, a leak was noticed in the disposable pressure transducer (dpt).In addition, the clinician stated that inaccurate values were obtained during use of this dpt.The product was exchanged.There was no allegation of patient injury.
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Manufacturer Narrative
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Per additional follow-up with the hospital, it was clarified that there were no inaccurate values during the reported event.It was discovered that the physician¿s initial statement that leakage in the dpt housing led to inaccuracy of the pressure data, was a statement based on assumption and not a statement of fact.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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