Vital SignsRecalls & reported problems across all models
AirLife Finland Oy · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 11 models of Vital Signs by AirLife Finland Oy in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2022 and May 4, 2026 — classified as 16 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Vital Signs problems
Device problems
- Connection Problem32
- Fitting Problem12
- Disconnection5
- Leak/Splash5
- Defective Component4
- Loose or Intermittent Connection4
- Appropriate Device Problem Term/Code Not Available3
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions73
Vital Signs models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vital Signs™ 2464AAO-20Electrode, electrocardiograph51 reports
- Vital Signs™ 7000AAOElectrode, Circular (Spiral), Scalp And Applicator8 reports
- Vital Signs™ M1024247Thermometer, Electronic, Clinical3 reports
- Vital Signs™ 2016560-002Cable, Electrode2 reports
- Vital Signs® M1152226Circuit, breathing (w connector, adaptor, y piece)2 reports
- Vital Signs™ 1591AAOCable, Electrode2 reports
- Vital Signs™ 2016560-001Cable, Electrode1 report
- Vital Signs™ 73319-HELAnalyzer, Gas, Oxygen, Gaseous-Phase1 report
- Vital Signs® M1090619Circuit, breathing (w connector, adaptor, y piece)1 report
- Vital Signs™ 1590AAOCable, Electrode1 report
- Vital Signs™ 8004463ANALYZER, GAS, OXYGEN, GASEOUS-PHASE1 report
Recent Vital Signs adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Mechanical Problem
IT WAS REPORTED THAT THE FETAL SCALP ELECTRODES ARE DIFFICULT TO DEPLOY DURING INSERTION DUE TO THE SLEEVE BECOMING STUCK, RESULTING IN DEVICE DISCARD AND THE NEED TO USE AN ADDITIONAL ELECTRODE. NO HARM WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068688 ↗MalfunctionNov 27, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
IT WAS REPORTED THAT "SPIRAL FETAL ELECTRODE BEING LEFT INSIDE A PATIENT FOLLOWING DELIVERY. IT (PART OF FSE) WAS LEFT INSIDE THE MOTHER FOLLOWING A C SECTION DELIVERY, IT WAS DISCONNECTED FROM THE BABY, THE BABY WAS OK AND WAS DELIVERED. IT HAPPENED DURING A SWAB', THE PART OF THE FSE WAS SHIFTED AND PUSHED FURTHER UP INTO THE MUM. THEY HAD DISCONNECTED THE FSE FROM THE BABY, HAD CUT THE WIRE AND THAT PART WAS LEFT INSIDE THE MUM".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793826 ↗MalfunctionSep 11, 2024Material Too Rigid or Stiff; Material Integrity Problem; Material Too Rigid or Stiff; Material Integrity Problem
CANNOT CONSISTENTLY ATTACH THE CABLE PORTION TO THE SET TO THE ATTACHMENT PAD. IT DOES NOT ALWAYS SNAP INTO PLACE. THE ADHESIVE ALSO DOES NOT STICK WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20195915 ↗MalfunctionFeb 22, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18758707 ↗MalfunctionFeb 16, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CIRCUIT E(A) 1.8M 1.5M-EXT 2L BAG GSE HAVE LEAKS. FURTHERMORE, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18727890 ↗MalfunctionFeb 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18695139 ↗MalfunctionFeb 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18695133 ↗InjuryFeb 3, 2024Disconnection; Disconnection
IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY ARE CURRENTLY TAPING DOWN THE 2464AAO-20 - LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE TO THE LEG PLATE SO THAT IT WILL STAY ATTACHED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18637036 ↗MalfunctionJan 19, 2024Partial Blockage; Partial Blockage
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 73319-HEL - GAS SAMPLING LINE, 10FT, M/M WAS PARTIALLY OCCLUDED, CAUSING THE ANESTHESIA MACHINE TO GO INTO A CHECK DEFEND ALARM STATUS. THOUGH THERE WERE HALF-HOUR DELAYS DURING THE SURGERY, THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18544347 ↗MalfunctionJan 14, 2024Disconnection; Disconnection
THE CUSTOMER REPORTED THAT THE LEG ATTACHMENT PAD WOULD NOT STAY CONNECTED TO THE CABLE. THE NURSE WILL PUSH DOWN AND PINCH IT, AND IT WILL TRANSMIT PROPERLY, BUT WHEN THEY LET GO, IT CREATES AN ARTIFACT, AND THE FETAL HEART RATE CANNOT BE TRACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509781 ↗MalfunctionJan 14, 2024Disconnection; Disconnection
THE CUSTOMER REPORTED THAT THE LEG ATTACHMENT PAD WOULD NOT STAY CONNECTED TO THE CABLE. THE NURSE WILL PUSH DOWN AND PINCH IT, AND IT WILL TRANSMIT PROPERLY, BUT WHEN THEY LET GO, IT CREATES AN ARTIFACT, AND THE FETAL HEART RATE CANNOT BE TRACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509777 ↗MalfunctionJan 14, 2024Disconnection; Disconnection
THE CUSTOMER REPORTED THAT THE LEG ATTACHMENT PAD WOULD NOT STAY CONNECTED TO THE CABLE. THE NURSE WILL PUSH DOWN AND PINCH IT, AND IT WILL TRANSMIT PROPERLY, BUT WHEN THEY LET GO, IT CREATES AN ARTIFACT, AND THE FETAL HEART RATE CANNOT BE TRACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509773 ↗MalfunctionDec 19, 2023Fitting Problem; Connection Problem; Fitting Problem; Connection Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN THE PROVIDER WAS ATTEMPTING TO PLACE A FETAL SCALP ELECTRODE ON A TRIAL OF LABOR AFTER A CESAREAN (TOLAC) PATIENT WHO WAS LABORING NATURALLY WITHOUT AN EPIDURAL, THE 7000AAO-ELECTRODES, FETAL SCALP (FSE), 50/CASE WOULD NOT STAY SNAPPED INTO PLACE OR STUCK TO THE PATIENT'S LEG AND THEREFORE WOULD NOT READ. A REGISTERED NURSE (RN) AT THE DESK RETRIEVED ANOTHER FETAL SCALP ELECTRODE (FSE) AND CORD FROM ANOTHER ROOM THAT WAS PLACED WITHOUT INCIDENT. THE PATIENT'S CURRENT STATUS IS STILL UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18361329 ↗MalfunctionDec 5, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8004463 EXHAUST LINE WITH COLDER WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271100 ↗MalfunctionOct 12, 2023Connection Problem; Connection Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THEY ARE ATTEMPTING TO PLACE FETAL SPIRAL ELECTRODE FOR COROMETRICS ON A TOLAC (TRIAL OF LABOR AFTER CESAREAN DELIVERY) PATIENT WHO WAS LABORING NATURALLY AND THE PRODUCT WOULD NOT STAY SNAPPED INTO PLACE NOR WOULD IT STICK YO THE PATIENT'S LEG. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17927783 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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