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Model Number 25335 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that the gauge needle failed to point accurate data.An encore 26 inflation device was selected for use.During the procedure, it was noted that the pointer could not move, and the gauge needle failed to point accurate data.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
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Event Description
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It was reported that the gauge needle failed to point accurate data.An encore 26 inflation device was selected for use.During the procedure, it was noted that the pointer could not move, and the gauge needle failed to point accurate data.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the gauge needle was at 0 atm when received.The device did not have visual defects.Functional testing of the complaint device (pressure damping test, vacuum test, side load test, gauge accuracy test, device locking mechanism test) was carried out and the unit passed all functional tests without issues.
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Search Alerts/Recalls
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