CAMINO® CAM02 (UDI 00382830049023)Recalls & reported problems
Natus Medical Incorporated · Intracranial Pressure and Temperature Monitor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382830049023), received between Jun 17, 2021 and Nov 4, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Sensing Problem1
- Electrical /Electronic Property Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024
PATIENT ON CAMINO ICP MONITOR. PATIENT WAS PLACED FLAT FOR CARE, CAMINO WITH BOLT INTACT. PATIENT HAD BEEN FOR ICP (INCREASED INTRACRANIAL PRESSURE) RANGE 3-5 JUMPED TO 18-19, NO CHANGE IN PATIENTS' ASSESSMENT. HOB (HEAD OF BED) ELEVATED WAVE CONSISTENT, THEN FLATTED. RESIDENT CALLED NATUS 24/7 CLINICAL SUPPORT. DURING TROUBLESHOOTING THE SCREEN PRESENTED TEMPERATURE NUMBERS ¿ [REDACTED NAME] DOES NOT USE TEMPERATURE INTEGRATION. THE SCREEN THEN FLASHED OUT OF THE TEMPERATURE RANGE. DUE TO THE CONCERN OF THE SCREEN AND INFLATED NUMBERS -BOLT REMOVED. BOTH THE CAMINO AND BOLT ARE BEING SENT TO THE COMPANY FOR FURTHER INSPECTION.
Patient problems: Insufficient Information
MAUDE report 20599744 ↗MalfunctionJul 11, 2024Break; Patient Data Problem; Break; Patient Data Problem
PART CAM02 - DISPLAY ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19724262 ↗MalfunctionJul 12, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
PART CAM02 - SYSTEM ERROR DETECTING A SENSOR BOARD FAILURE. DETAILS FROM THE CUSTOMER AS BELOW: *-JUNE 15, SENSOR PLACEMENT IS CARRIED OUT, EQUIPMENT WORKING IN PERFECT CONDITION, PROPER FUNCTIONING IS CONFIRMED WITH THE DOCTOR. *-PATIENT HOSPITALIZED IN ICU, WITH PIC INTERVALS 15 TO 20 MM HG. *-5 DAYS THE EQUIPMENT WORKING NORMALLY. * -6 DAYS IN THE MORNING, THE SCREEN SHOWED A SYSTEM ERROR DETECTING A FAILURE IN THE SENSOR CARD. *- FROM THEN ON, NO MORE ICP INTERVALS WERE SHOWN, UNIT WAS SWAPPED OUT WITH ANOTHER TO CONTINUE PATIENT MONITORING. NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17306796 ↗MalfunctionJun 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem
CUSTOMER DOCUMENTED INCONSISTENT ICP MEASUREMENTS INVOLVING THE CAM02. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018138 ↗
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- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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