NEUROVENT-IFD-R 095317-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04057834029338), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2019Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Material Separation

  THE CLINIC PLACED AN ICP/DRAIN (N-IFD-R) ON (B)(6) 2019. THEN ON (B)(6) 2019 INACCURATE ICP VALUES WERE READING IN THE 70'S BUT ONLY STRAIGHT LINE NO WAVEFORM. ON (B)(6) 2019 AN EVD DRAIN WAS CONNECTED TO THE N-IFD-R, SO AN ICP MONITORING WAS POSSIBLE AND ALSO WAVEFORM AND READINGS OF 16-18 COULD BE MONITORED, WHICH IS WHAT PATIENT HAD BEEN READING PREVIOUSLY. ON (B)(6) 2019 THE CLINIC DECIDED TO APPLICATE ANOTHER ICP CATHETER TO OBTAIN ACCURATE CONTINUOUS ICP READINGS. LEFT THE N-IFD-R IN TO CONTINUE DRAINAGE. THEN ON (B)(6) 2019 THE EVD CONNECTION BETWEEN N-IFD-R AND EVD DRAIN CAME APART AND STARTED LEAKING CSF. THE CLINIC DECIDED THEY NEED TO ATTEMPT TO REPAIR THE LEAKAGE AS PHYSICIAN FELT HE WOULD NOT BE ABLE TO PLACE ANOTHER CATHETER BASED ON THE SIZE OF THE VENTRICLES. THE CLINIC STARTED PATIENT ON PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2019 THE CLINIC REMOVED THE SYSTEM N-IFD-R / EVD. PATIENT WOKE UP MOVING EXTREMITIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8738409 ↗