Camino® CAM02 (UDI 10381780039310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10381780039310), received between Nov 15, 2017 and Dec 3, 2019 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2019Failure to Run on Battery; Failure to Run on Battery

  MONITOR CURRENTLY PLUGGED IN, HOWEVER EXTERNAL BATTERY INDICATOR SHOWS AS NOT CHARGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9402902 ↗
• MalfunctionNov 26, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CAM02 NO LONGER READS CORRECTLY AFTER PATIENT WAS TRANSFERRED TO THEIR PROCEDURE. CUSTOMER CONFIRMS CATHETER WAS ZEROED PRIOR TO PROCEDURE, AND CAM02 MONITOR AND CAMCABLS WERE SWAPPED OUT, ISOLATING CATHETER FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376163 ↗
• MalfunctionNov 26, 2019Output Problem; Output Problem

  CAM02 UNIT IS EXPERIENCING CATHETER FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376141 ↗
• MalfunctionOct 29, 2019No Device Output; No Device Output

  PATIENT CONNECTED TO CATHETER, THEN TO MONITOR WHICH DID NOT SHOW RESPONSE. MONITOR REPLACED WITH A BACKUP UNIT WHICH RESPONDED AS EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252776 ↗
• MalfunctionApr 24, 2019Unable to Obtain Readings; Unable to Obtain Readings

  MEDICAL INTERVENTION NEEDED AFTER MONITOR DID NOT DISPLAY CORRECT VALUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544762 ↗
• MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CATHETER SHOWS TO HAVE FAILED ON MONITOR AFTER INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533483 ↗
• MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CAM02 UNIT DISPLAYS ERROR CODE WHICH CAUSED DELAY IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533480 ↗
• MalfunctionAug 27, 2018Power Problem; Power Problem

  THE FOLLOWING WAS REPORTED BY A USER FACILITY: (B)(4), WAS ON A PATIENT (B)(6) 2018 AND AT APPROX 5PM, A PROBLEM WAS REPORTED: MONITOR SHUT OFF COMPLETELY AND WAS UNABLE TO BE RESTARTED. WHEN ATTEMPTED TO TURN IT BACK ON SYSTEM SAID IT NEEDED TO BE SERVICED. NEURO SURGERY CALLED AND BOLT HAD TO BE PULLED OUT AND REPLACED. ICP WAS UNABLE TO BE MONITORED FOR 2 HOURS DUE TO MALFUNCTION ON A PATIENT WITH HIGH ICP'S THAT WE WERE ACTIVELY TREATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820514 ↗
• MalfunctionAug 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE FOLLOWING WAS REPORTED BY THE SITE/ USER FACILITY REGIONAL SALES DIRECTOR: "THE SITE IS EXPERIENCING LARGE SWINGS IN READINGS TO THE NEGATIVE SIDE AFTER THE CATHETER HAS BEEN ZERO'D AND PLACED. THIS IS OCCURRING POSSIBLY 24-48 HOURS INTO USE. THE CUSTOMER HAS BEEN ABLE TO SWAP MONITORS TO GET A POSITIVE READING". ADDITIONAL INFORMATION: MONITOR DATA LOGS SHOWED MULTIPLE CODES/ ERRORS. THE FACILITY LEFT CABLES AND CATHETER CONNECTED TO PATIENT, SWITCHED MONITOR, AND ISSUE RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810126 ↗
• MalfunctionJun 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CAM02 (B)(4) NOT READING CORRECTLY. ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL ON 18 JUNE 2018: DEVICE WAS ATTACHED TO PATIENT AT THE TIME OF THE INCIDENT. NO INJURY TO THE PATIENT; DEVICE WAS CHANGED OUT; THERE WAS SOME DELAY IN SURGERY, BUT NOT A SIGNIFICANT ONE. INCIDENT DATE IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641888 ↗
• MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue

  THE 110 4 B OLM PARENCHYMAL CATHETER CONNECTED TO CAMINO MONITOR SERIAL NUMBER (B)(4), STATUS BAR INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". SURGEON REPLACE INITIAL 110 4 B CATHETER WITH ANOTHER 110 4 B CATHETER, AND RECEIVED THE SAME READINGS - INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". CAMINO MONITOR SERIAL NUMBER (B)(4) WAS SWITCHED OUT WITH DIFFERENT MONITOR, WITH SECOND CATHETER, AND RECEIVED NO ERROR MESSAGES. CATHETER PERFORMED NORMALLY AFTER SWITCHING OUT MONITOR. NO ALLEGED DEATH/ INJURY. PATIENT INFORMATION: NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638161 ↗
• MalfunctionJun 12, 2018Invalid Sensing; Invalid Sensing

  MONITOR IS SHOWING INCORRECT READING (HALF OF CAMINO OUTPUT IS BEING DISPLAYED). DELAY IN SURGERY: UNKNOWN WAS THERE ANY PATIENT INJURY/ DEATH ALLEGED: NO ANY REVISIONS/MEDICAL INTERVENTIONS REQUIRED: MONITOR COULD NOT BE CONNECTED TO EPIC (EMR) / LOCAL MONITOR AS DATA INCORRECT - VALUES HAD TO BE MANUALLY CHARTED WAS THE PATIENT (S) PREPPED FOR SURGERY: NO ANY DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO ANY DELAY IN SURGERY DUE TO PRODUCT PROBLEM(S): NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593154 ↗
• MalfunctionJun 8, 2018Invalid Sensing; Invalid Sensing

  CAMINO MONITOR DISPLAYING HALF THE ACTUAL READING. PATIENT INFORMATION: (B)(6). INCIDENT DATE: (B)(6) 2018. WAS THERE ANY PATIENT INJURY/ DEATH ALLEGED: NO. ANY REVISIONS/MEDICAL INTERVENTIONS REQUIRED: MONITOR COULD NOT BE CONNECTED TO EPIC (EMR) / LOCAL MONITOR AS DATA INCORRECT - VALUES HAD TO BE MANUALLY CHARTED. WAS THE PATIENT (S) PREPPED FOR SURGERY: NO. ANY DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO. ANY DELAY IN SURGERY DUE TO PRODUCT PROBLEM(S): NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7583376 ↗
• MalfunctionJun 5, 2018Invalid Sensing; Invalid Sensing

  THE MONITOR IS SHOWING WRONG RESULTS. USED OTHER DEVICE. DELAY IN SURGERY DUE TO PRODUCT PROBLEM? NO. PART/PRODUCT BEING RETURNED? YES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569225 ↗
• MalfunctionMay 24, 2018Device Operational Issue; Device Operational Issue

  NATUS RECEIVED A COMPLAINT REPORTING THE FOLLOWING: "TOUCH SCREEN NOT RESPONDING. THE SYSTEM IS IN USE, CONNECTED TO A PATIENT. CALIBRATION DUE DATE 5/15" TWO ATTEMPTS HAVE BEEN MADE TO COLLECT ADDITIONAL INFORMATION: 04MAY2018: ATTEMPT TO COLLECT ADDITIONAL INFORMATION. ON 24MAY2018: ATTEMPT TO COLLECT ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542847 ↗
• MalfunctionMay 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE FOLLOWING WAS REPORTED FROM A USER FACILITY "THE LAST PATIENT THAT HAD THE CAMINO BOLT IN PLACE WE NOTED THAT THE CAMINO CONSOLE AND THE PHILIPS MONITOR WERE NOT SHOWING THE SAME NUMBER. WE REPEATEDLY TRIED TO SYNCH THE MONITORS TOGETHER AS WELL AS CHANGED OUT THE CORDS BUT THE CAMINO WOULD READ 2-3 POINTS LESS THAN THE PHILIPS MONITOR NUMBER CONSISTENTLY. OUR PHILIPS MONITORS AUTOMATICALLY DOWNLOAD TO OUR EMR SO THE NURSING STAFF HAD TO TAKE THE PHILIPS VALUE OUT OF THE CHARTING AND CHART THE NUMBER FROM THE CAMINO." NO PATIENT INJURY OR DEATH ASSOCIATED. NO DELAY IN SURGERY. PATIENT WAS (B)(6), MALE. HIGH SPEED MVC. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17APRIL2018: "WHEN I LOOKED AT IT DURING SET UP, CAM02 MONITOR READ 25 AND PHILIPS MONITOR DISPLAYED 24 ON ITS SCREEN. AT 50 PHILIPS MONITOR READ 49 AND 100 READ 99 ON PHILIPS MONITOR. IT DID HOW EVER GO BACK TO ZERO ON BOTH. SO BASICALLY THE CAM02 MONITOR IS NOT SYNCING CORRECT NUMBER DISPLAYED TO THE PHILIPS MONITOR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504354 ↗
• MalfunctionMar 15, 2018Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  CAMINO (B)(4) SYSTEM REQUIRES AN ANNUAL SERVICE/CALIBRATION. ALSO REPORTED THAT THEY RECENTLY USED THIS MONITOR ON A PATIENT AND IT WAS READING 300 MMHG, WHEN CHANGED TO A DIFFERENT MONITOR THE READINGS WERE NORMAL. DATE OF INCIDENT: (B)(6) 2018. DEVICE IN CONTACT WITH PATIENT: YES. PATIENT INJURY/ DEATH ALLEGED: NO. REVISION/MEDICAL INTERVENTION REQUIRED: UNK. PATIENT PREPPED FOR SURGERY: NO. PATIENT INFORMATION: UNKNOWN. DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO. DELAY IN SURGERY DUE TO PRODUCT PROBLEM: UNK. OUT OF BOX FAILURE (OOB): NO. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7343241 ↗
• MalfunctionJan 12, 2018Device Operational Issue; Device Operational Issue

  FROM ORIGINAL E-MAIL SENT TO INTEGRA 05 DEC 2017: "I HAVE CAMINO, ICP, CAM02, THAT HAS A TOUCH PROBLEM. I WOULD LIKE TO SEND THIS UNIT FOR REPAIR." FROM THE MINIMUM COMPLAINT INFORMATION FORM RECEIVED FROM INTEGRA ON 05 DEC 2017: "PATIENT INJURY/ DEATH ALLEGED: NO" "REVISION/MEDICAL INTERVENTION REQUIRED: NO" "OUT OF BOX FAILURE(OOB): NO" "DID PRODUCT FAIL DURING COMMISSIONING, DECONTAMINATION OR SETUP PROCEDURES PRIOR TO FIRST CLINICAL USE? NO" AS NO PATIENT RELATED INFORMATION WAS PROVIDED, INCLUDING POSSIBLE DELAY IN CARE, A FOLLOW-UP REQUEST WAS SENT 13 DEC 2017 TO THE REPORTER. A RESPONSE WAS IMMEDIATELY RECEIVED WITH SOME OF THE REQUESTED INFORMATION. "THE ISSUE WAS DISCOVERED PRIOR TO DEVISE USAGE. NO REPORT TO FDA SUBMITTED". NO FURTHER INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7188508 ↗
• MalfunctionDec 28, 2017Device Operational Issue; Device Operational Issue

  FROM THE MINIMUM COMPLAINT INFORMATION FORM RECEIVED (B)(6) 2017 FROM INTEGRA LIFESCIENCES: CUSTOMER STATED THAT THE, TOUCH SCREEN LOCKED UP. ALSO INDICATED ON THE ABOVE MENTIONED FORM: OUT OF BOX FAILURE(OOB): NO. DID THE PRODUCT FAIL DURING COMMISSIONING, DECONTAMINATION OR SETUP PROCEDURES PRIOR TO FIRST CLINICAL USE? NO. AS NO INFORMATION REGARDING THE PATIENT OR POTENTIAL IMPACT ON THE PATIENT WAS PROVIDED, A FOLLOW-UP E-MAIL WAS SENT BY (B)(4) ON (B)(6) 2017 REQUESTING FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151654 ↗
• MalfunctionDec 27, 2017Invalid Sensing; Invalid Sensing

  FROM THE MINIMUM COMPLAINT INFORMATION FORM RECEIVED 27 NOV 2017 FROM INTEGRA LIFESCIENCES: "ACCORDING TO CUSTOMER, MONITOR , "TEMPERATURE IS READING INACCURATELY. DISPLAYED TEMP IS READING AT 31.9°C; THERMOMETER IS READING 30.2°C."" FROM THE SAME FORM: "OUT OF BOX FAILURE(OOB): NO" "DID PRODUCT FAIL DURING COMMISSIONING, DECONTAMINATION OR SETUP PROCEDURES PRIOR TO FIRST CLINICAL USE? NO" AS NO OTHER INFORMATION WAS PROVIDED RELATED TO POTENTIAL IMPACT ON A PATIENT, AN E-MAIL WAS SENT 13 DEC 2017 REQUESTING MORE INFORMATION.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7150096 ↗
• MalfunctionDec 27, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  FROM THE MINIMUM COMPLAINT INFORMATION FORM RECEIVED (B)(4) 2017 FROM INTEGRA LIFESCIENCES: "ACCORDING TO CUSTOMER, MONITOR IS DISPLAYING ERROR E2057-SENSORBOARD FAILURE. THIS HAPPENED DURING A PROCEDURE. MONITOR IS STILL COVERED UNDER MANUFACTURER WARRANTY." THE FORM INDICATED THE FOLLOWING; "PATIENT PREPPED FOR SURGERY: YES" "OUT OF BOX FAILURE(OOB): NO" "DID PRODUCT FAIL DURING COMMISSIONING, DECONTAMINATION OR SETUP PROCEDURES PRIOR TO FIRST CLINICAL USE? NO" AS NO OTHER INFORMATION REGARDING THE PATIENT AND PATIENT IMPACT WAS PROVIDED, A FOLLOW-UP E-MAIL WAS SENT (B)(6) 2017 TO THE USER FACILITY REQUESTING ADDITIONAL INFORMATION. A REPLY WAS RECEIVED ON (B)(6) 2017: "WAS THERE AN INJURY TO THE PATIENT? NO" "WAS ANY MEDICAL INTERVENTION REQUIRED? NO" "WAS THERE A DELAY IN SURGERY CAUSED BY THE PRODUCT ISSUE? NO"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149861 ↗
• MalfunctionNov 30, 2017Device Operational Issue; Device Operational Issue

  FROM THE MINIMUM COMPLAINT INFORMATION FORM: "AFTER INSTALLATION, 3 MINUTES LATER, CAMINO ICP MONITOR CONSOLE SHOW BLACK SCREEN, THE SYSTEM FAILURE. RESTART AGAIN, THE ICP MONITOR WORKS AGAIN. (B)(6), CUSTOMER COMPLAINT, THE ICP MONITOR SHOW WITH BLUE SCREEN FREQUENTLY AFTER START THE DEVICE WITHIN HALF HOUR, ALSO COULD NOT SEE ANY DATA." "DEVICE IN CONTACT WITH PATIENT: NO." "PATIENT INJURY/DEATH ALLEGED: NO." "REVISION/MEDICAL INTERVENTION REQUIRED: NO." "PATIENT PREPPED FOR SURGERY: YES." "DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO." "DELAY IN SURGERY DUE TO PRODUCT PROBLEM: YES." "OUT OF BOX FAILURE(OOB): YES." "DID PRODUCT FAIL DURING COMMISSIONING, DECONTAMINATION OR SETUP PROCEDURES PRIOR TO FIRST CLINICAL USE? YES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071002 ↗
• MalfunctionNov 29, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  FROM COMPLAINT INFORMATION FORM RECEIVED 30 OCT 2017: "SENSOR BOARD FAILURE ERROR CODE 2057" "DID IT RESULT IN DEATH? NO". "DID PRODUCT MALFUNCTION? YES". WHEN THE CUSTOMER REPORTED THIS INCIDENT, THE CUSTOMER WAS NOTIFIED THAT THE SERIAL # ASSOCIATED WITH THE COMPLAINT WAS IN NEED OF A SPEAKER UPDATE WHICH HAD BEEN THE SUBJECT OF A RECALL BY INTEGRA (REF. Z-1618-2015). INFORMATION RECEIVED BY E-MAIL (B)(6) 2017 IN RESPONSE TO FIRST FOLLOW-UP REQUEST: "REVISION/MEDICAL INTERVENTION REQUIRED? NO." "OUT OF BOX FAILURE: NO". ADDITIONAL INFORMATION RELATED TO INCIDENT WILL BE REQUESTED. IT IS UNKNOWN WHETHER THE ERROR OCCURED BEFORE, DURING, OR AFTER SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7069280 ↗
• MalfunctionNov 15, 2017Unable to Obtain Readings; Unable to Obtain Readings

  UPDATE 21 JAN 2018. A REQUEST WAS MADE 13 DEC 2017 FOR PATIENT INFORMATION. A RESPONSE WAS RECEIVED LATER THAT DAY. "NOT THE END USER. AM THIRD PARTY BIOMED. UNIT WAS FOUND IN SHOP WHEN I ARRIVED. DURATION IN SHOP OVER 6 MONTHS. UNABLE TO PROVIDE THIS INFORMATION." AS THERE IS NO INFORMATION RELATED TO THE PATIENT OR ACTUAL INCIDENT, THE REPORT IS BEING UPDATED FROM AN "ADVERSE EVENT" TO A "PRODUCT PROBLEM".

  Patient problems: No Information

  MAUDE report 7036038 ↗
• MalfunctionNov 15, 2017Device Operational Issue; Device Operational Issue

  ADDITIONAL INFORMATION PROVIDED 13 DEC 2017 TO NATUS FROM THE NATUS CLINICAL SPECIALIST: "WAS ANY MEDICAL INTERVENTION REQUIRED? [?] YES [?] NO [?] UNK - NO" "PATIENT: AGE GENDER: [?] MALE [?] FEMALE WEIGHT - UNKNOWN" ""OPERATOR OF DEVICE" OR, WHO WAS USING IT WHEN THE MALFUNCTION OR INJURY WAS OBSERVED? (BY PROFESSION SUCH AS "PHYSICIAN", MED TECH, ETC.) PHYSICIAN" "DATE THE CATHETER WAS PLACED, IF APPLICABLE: UNKNOWN" "DATE THE CATHETER WAS REMOVED, IF APPLICABLE: UNKNOWN" "WAS A USER FACILITY REPORT SUBMITTED TO FDA? [?] YES [?] NO - NO" NO FURTHER REQUESTS FOR INFORMATION RELTED TO THE INCIDENT WILL BE MADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7034549 ↗