Sophysa PSO-PTTRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03760124131765), received between Dec 31, 2020 and Dec 8, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (11 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Incorrect Measurement; Incorrect Measurement

  DISCREPANCIES IN ICP CATHETER READING. LARGE FLUCTUATIONS. SIMILAR ISSUES WITH THE NEW CATHETER INSERTED AFTER. PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2025 WITH HIGH ICP FOR AN EXTERNAL VENTRICULAR DRAIN. TIME OF IMPLANTATION: (B)(6) 2025. TIME OF EXPLANATION: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742816 ↗
• MalfunctionDec 5, 2025Device Sensing Problem; Unexpected Shutdown; Device Sensing Problem; Unexpected Shutdown

  CATHETER OPENED AND NOT WORKING WHEN CONNECTED TO THE MONITOR. TO ISOLATE FAULT, CONNECTING CABLE CHANGED, NOT OPERATIONAL, MONITOR CHANGED, NOT OPERATIONAL. NEW CATHETER OPENED AND CONNECTED TO MONITOR, OPERATIONAL AND CATHETER INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727614 ↗
• MalfunctionOct 15, 2025Unexpected Shutdown; Unexpected Shutdown

  SENSOR WAS IMPLANTED AND WORKING WELL. NURSE HAS DISCONNECTED SENSOR FROM MONITOR TO DO SOMETHING WITH PATIENT. THEY HAS TRIED TO RECONNECTED THE SENSOR TO THE MONITOR, TO WHICH THE MONITOR THEN WAS MAKING SOUND AND TURNING ON AND TURNING OFF. THEY TRIED 4 OTHER MONITORS AND THE SAME ISSUE HAPPENED WITH ALL 4 MONITORS. ALL 4 MONITORS KEPT TURNING OFF AND ON WHEN CONNECTED TO THE SENSOR. 2 MONITORS WOULD SHOW A WAVE FORM AND PRESSURE FOR 10 SECONDS THEN SHUT OFF AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290920 ↗
• MalfunctionOct 9, 2025Incorrect Measurement; Incorrect Measurement

  PT HAS ICP SENSOR IMPLANTED FOR 3 DAYS NO ISSUES. HOWEVER, POST A ROLL (REPOSITIONING THE PT), THE MONITOR WAS SHOWING NEGATIVE ICP VALUES OR PERIODICALLY NO WAVE FORM/VALUES. THE NURSE AND EQUIPMENT NURSE TROUBLE SHOOTED WITH A DIFFERENT CONNECTION CABLE AND DIFFERENT MONITORS AND WAS STILL RECEIVING THE SAME ISSUE. NO ERROR MESSAGE WAS DISPLAYED ON THE MONITOR. THEY THEN USED A TRANSDUCER FROM THE EVD TO OBTAIN AN ICP VALUE. EQUIPMENT NURSE CALLED ME AT 1550 TO LET ME KNOW AND HELP WITH TROUBLE SHOOTING, THEY HAD DONE ALL THEY COULD AND WHAT WAS NEEDED TO BE DONE. I SAID IT WAS LIKELY DUE TO THE SENSOR BEING DISLODGED HOWEVER STRANGE THERE WASNT AN ERROR MESSAGE. SENSOR WAS EXPLANTED LATER THAT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254736 ↗
• MalfunctionSep 22, 2025Incorrect Measurement; Incorrect Measurement

  THE CATHETER WAS IMPLANTED THE (B)(6). EXTERNAL VENTRICULAR DRAIN AND INTRACRANIAL PRESSURE WERE CORRELATED UNTIL THE (B)(6). AT 10PM THE READING OF THE INTRACRANIAL PRESSURE BECAME HIGH, INCREASED UP TO 57. THE CATHETER WAS EXPLANTED ON (B)(6) 2025. THE CATHETER WAS INITIALLY CHECKED AND WAS IN POSITION IN THE BRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109258 ↗
• MalfunctionSep 15, 2025Unexpected Shutdown; Unexpected Shutdown

  AFTER PERFORMING THE ZEROING PROCEDURE ON THE PIC CATHETER SENSOR, WHEN INITIATING THE MEASUREMENT OF ICP AND ICT VALUES, THE MONITOR WOULD AUTOMATICALLY SHUT DOWN AND RESTART. IN ORDER TO EXCLUDE THE POSSIBILITY OF A MALFUNCTION RELATED TO THE MONITOR OR THE CONNECTING CABLE, BOTH COMPONENTS WERE REPLACED AND THE SENSOR WAS TESTED ON FOUR DIFFERENT MONITORS. HOWEVER, IN ALL 4 CASES, AFTER 45 TO 60 SECONDS OF MEASUREMENT, THE MONITOR REPEATEDLY RESTARTED. AS IT WAS NOT POSSIBLE TO MAINTAIN CONTINUOUS MONITORING, IT BECAME NECESSARY TO REPLACE THE SENSOR WITH A NEW ONE, WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051602 ↗
• MalfunctionJul 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ICP READINGS FOR UP TO 10 HOURS. PATIENT WENT TO CT. WHEN CONNECTING THE ICP CATHETER BACK TO THE MONITOR NO READING COULD BE OBTAINED. NOTED CONNECT CATHETER. A SECOND PRESSIO2 AND CABLES WERE USED. STILL UNABLE TO GET A READING. ICP CATHETER EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662991 ↗
• MalfunctionJul 29, 2025Unexpected Shutdown; Unexpected Shutdown

  PATIENT MONITORED IN ICU FOR 10 HOURS. THE PRESSIO2 MONITOR BATTERY DEPLETED AS IT WAS NOT PLUGGED IN. WHEN PLUGGED IN, CATHETER DID NOT READ. MONITOR FLASHED, TICKED OVER (MADE A NOISE). TRIED A NEW MONITOR AND CABLES WITH THE CATHETER. MONITOR FLASHED, WOULD NOT ACCEPT CATHETER. CATHETER WAS NOTED AS PLACED CORRECTLY VIA MRI. EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643138 ↗
• MalfunctionJul 25, 2025Incorrect Measurement; Incorrect Measurement

  ICP CATHETER (REFERENCED PSO-PTT) WAS IMPLANTED ON THE (B)(6) 2025 IN CORRECT POSITION. THE ICP READING AND EVD READING DID NOT MATCH AT ALL DURING IMPLANTATION. REPORTED INCONSISTENT PSO-PTT READING 4, EVD READING 14. DEF UNUSUAL READING ON THE (B)(6). REMOVED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606880 ↗
• MalfunctionJul 17, 2025Incorrect Measurement; Incorrect Measurement

  ICP CATH IMPLANTED AND REMOVED 3 DAYS LATER DUE TO INCONSISTENT ICP LVLS WHICH DID NOT CORRELATE TO THE PATIENT CLINICAL STATE. ICP READING ON DAY 2 STARTED READING 40 AND WOULD SWING BETWEEN -25 TO 35 WITH NO CLINICAL CHANGE TO PATIENT. WHEN THE CONSULTANT PRESSED ON THE PATIENT'S BRAIN THE READING WENT DOWN. THIS CATHETER WAS REMOVED AND REPLACED WITH AN EVD. CATHETER CHECKED FOR CORRECT POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529939 ↗
• MalfunctionJul 17, 2025Incorrect Measurement; Incorrect Measurement

  ICP CATHETER IMPLANTED (B)(6). NEGATIVE READING OF 1-2 INITIALLY, GOOD WAVEFORM. THE FOLLOWING MORNING ICP HAD GRADUALLY DECREASED -10 -12 READINGS & WAVEFORM DAMPENED. MRI NOTED CORRECT POSITION. CONNECTING CABLES, NO CHANGE IN READING. PHILLIPS MONITOR REPLICATED THE P2 READING. PATIENT TAKEN BACK TO OT. CATHETER EXPLANTED AND A NEW ONE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529534 ↗
• MalfunctionJun 27, 2025Unexpected Shutdown; Unexpected Shutdown

  CATHETER WAS IMPLANTED IN PATIENT IN THEATRE UNDER NORMAL CONDITIONS. ONCE PROCEDURE WAS COMPLETED, PATIENT WAS SENT TO THE WARD FOR MONITORING AT WHICH TIME THE CONSOLE HAD TURNED OFF AND COULD NOT BE TURNED BACK ON. MONITOR WAS CONNECTED VIA AC POWER CABLE AND HAD SUFFICIENT BATTERY POWER. A DIFFERENCE CATHETER CABLE WAS SWAPPED OUT BY STAFF; HOWEVER, THE MONITOR STILL DID NOT TURN ON. A SECOND MONITOR WAS INSTALLED AT WHICH TIME THE MONITOR DID WORK FOR A SHORT PERIOD OF TIME UNTIL IT TURNED OFF AND COULD NOT BE TURNED BACK ON. ONCE THE CATHETER WAS DISCONNECTED FROM THE CONSOLE THE MONITOR WAS ABLE TO BE POWERED BACK UP BUT AS SOON AS THE CATHETER WAS RECONNECTED THE MONITOR TURNED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344216 ↗
• MalfunctionFeb 14, 2025Unexpected Shutdown; Unexpected Shutdown

  ICP CATHETER INSERTED. READING WAS 7. CATHETER DISCONNECTED FROM PRESSIO2 WHILST PT MOVED ONTO NEW BED AND RECONNECTED. CATHETER WAS HELD/SUPPORTED BY REG, NO PULLING FROM PT END OF SENSOR END. INITIALLY OK WHEN RECONNECTED TO P2 UNIT THEN THE SCREEN STARTED FLASHING AND SCREEN WENT BLACK. BATTERY ON TWO BARS. PT SENT TO ICU AND MONITOR PLUGGED IN. SAME AGAIN, SCREEN FLASHED AND THE WENT BLACK. TRIED TWO OTHER PRESSIO2 MONITORS AND THE SAME HAPPENED. CATHETER EXPLANTED AND NEW CATHETER INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21382811 ↗
• MalfunctionSep 6, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DISTURBANCES ON THE ICP CURVE ON THE PRESSIO WHEN ON POWER BUT OK WHEN RUNNING ON THE BATTERIES. ICP VALUE JUMPS BETWEEN 0 TO 100 MMHG QUICKLY (WITHIN ONE SECOND).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156656 ↗
• MalfunctionSep 6, 2024Incorrect Measurement; Incorrect Measurement

  THE MONITOR SHOWED 17 MMHG WHEN THE CATHETER WAS CONNECTED. THE PIC WAS CONSIDERED TO BE ABNORMALLY HIGH CONSIDERING THE STATE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156652 ↗
• MalfunctionSep 6, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DISTURBANCES ON THE ICP CURVE ON THE PRESSIO WHEN ON POWER BUT OK WHEN RUNNING ON THE BATTERIES. MEAN ICP VALUE SEEMS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156639 ↗
• MalfunctionAug 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  WHEN CATHETER WAS REMOVED, IT WAS NOTICED THAT CATHETER TIP WAS MISSING. SCAN WAS BEING CONDUCTED OF THE PATIENT TO LOCATE THE TIP. LATER THE SAME DAY, THE MISSING TIP WAS ABLE TO BE RETRIEVED WITH RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19891159 ↗
• MalfunctionJun 17, 2024Signal Artifact/Noise; Incorrect Measurement; Signal Artifact/Noise; Incorrect Measurement

  DISTURBANCES ON THE ICP CURVE ON THE PRESSIO WHEN ON POWER BUT OK WHEN RUNNING ON THE BATTERIES. ICP VALUE JUMPS BETWEEN 0 TO 70 MMHG. THE ICT SHOWN ON PHILIPS PATIENT MONITOR WAS OFF BY AS MUCH 0,5 DEGREES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547234 ↗
• MalfunctionApr 23, 2024Incorrect Measurement; Incorrect Measurement

  ICP VALUES INCONSISTENT WITH PATIENT STATUS (INDICATING NEGATIVE VALUES) DURING CLINICAL FOLLOW-UP, LEADING TO DEVICE EXPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161643 ↗
• MalfunctionNov 27, 2023Device Sensing Problem; Device Sensing Problem

  THE MACHINE SHOWED E005 AFTER THE CATHETER WAS IMPLANTED FOR 12 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208239 ↗
• MalfunctionJun 1, 2023Incorrect Measurement; Incorrect Measurement

  CATHETER SHOWED NORMAL ICP FOR SOME HOURS, BUT AFTER X-RAY THE ICP CURVE STARTED TO CHANGE AND AT THE SAME TIME SHOWED INCREDIBLE VALUES. PRESSURE GAUGE LOOKED LIKE IT WAS SITTING WHERE IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037860 ↗
• MalfunctionNov 22, 2022Incorrect Measurement; Incorrect Measurement

  PSO-PTT ICP MONITORING DEVICE WAS IMPLANTED WITHOUT COMPLICATIONS. ONE DAY AFTER IMPLANTING THE DEVICE, THE TEMPERATURE MEASUREMENT REPORTEDLY DROPPED FROM 37°C TO 34°C WHICH DID NOT CORRELATE WELL WITH THE PATIENT'S HEALTH STATE. AFTER EXPLANTATION, WHEN THE CATHETER WAS TESTED, THE TEMPERATURE COULD ONLY REACH 34.9°C. NO HEALTH COMPLICATIONS OR MEDICAL CONSEQUENCES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841846 ↗
• MalfunctionDec 31, 2020Use of Device Problem; Use of Device Problem

  24H AFTER IMPLANTATION, THE CATHETER SHOWED AN ERROR MESSAGE E001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11100327 ↗