RD rainbow SET™ R25-12 RD rainbow SET Series Patient Cable 4078Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00843997010665), received between Jan 7, 2018 and Nov 26, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT THE CABLE CAUSED A "SENSOR MALFUNCTION" ERROR TO DISPLAY ON THE HOST MONITOR. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782581 ↗
• MalfunctionSep 20, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED "THE CABLE STOPPED RESPONDING WITH THE MONITOR. IT WAS PLUGGED AND UNPLUGGED SEVERAL TIMES. THE PULSE OXIMETER (PULSE OX) ON THE PATIENT WAS TRIED WITH ANOTHER NEW CABLE AND THE PULSE OX WAS THEN READ BY THE MONITOR. THIS WAS QUICKLY FIXED AND DID NOT IMPACT THE PATIENT FOR MORE THAN A FEW MINUTES. HEART RATE (HR) ON THE MONITOR WAS READING APPROPRIATELY DURING THIS TIME." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786429 ↗
• MalfunctionAug 30, 2023

  MODEL 4078 - THE CABLE STOPPED RESPONDING WITH THE MONITOR. IT WAS PLUGGED AND UNPLUGGED SEVERAL TIMES. THE PULSE OXIMETER (PULSE OX) ON THE PATIENT WAS TRIED WITH ANOTHER NEW CABLE AND THE PULSE OX WAS THEN READ BY THE MONITOR. THIS WAS QUICKLY FIXED AND DID NOT IMPACT THE PATIENT FOR MORE THAN A FEW MINUTES. HEART RATE (HR) ON THE MONITOR WAS READING APPROPRIATELY DURING THIS TIME. GIVEN TO REPRESENTATIVE. MODEL 4013 - PATIENT BORN VIA C-SECTION. FOLLOWING DELIVERY, A PULSE OXIMETER USED IN THE NEONATAL ROOM WAS APPLIED TO PATIENT'S RIGHT HAND. UNABLE TO GET AN OXYGEN SATURATION READING UNTIL THE HAND WAS PHYSICALLY HELD BY THE PROVIDER WITH ZERO MOVEMENT. IT TOOK APPROXIMATELY 3 MINUTES FOLLOWING DELIVERY TO OBTAIN ANY SATURATION READING. ACCORDING TO THE PROVIDER TALKED TO, THIS HAPPENS AT MOST DELIVERIES AND PEOPLE ARE "USED TO IT" TAKING SO LONG TO OCCUR. PROBE OR CABLE NOT SAVED. MODEL 4478, PULSE OX WAS NOT READING APPROPRIATELY. WHEN ON PATIENT'S FOOT, IT WOULD FAIL TO PICK-UP ANY READINGS. WHEN DISCONNECTED AND RECONNECTED, IT PICKED UP BRIEFLY, BUT DID NOT GIVE AN ACCURATE READING (POOR PHOTOPLETHYSMOGRAPH AND PULSE READING ON PULSE OXIMETER DID NOT CORRELATE WITH ELECTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649914 ↗
• MalfunctionJun 24, 2022Device Alarm System; Sensing Intermittently; Device Alarm System; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE CABLE WAS NOT READING ANY SATURATION AT ALL AND HAD TURNED ITSELF OFF WITH NO ALARM TO INDICATE CESSATION OF MONITORING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806835 ↗
• MalfunctionApr 22, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE LOOSE CONNECTION CAUSED INTERMITTENT READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190517 ↗
• MalfunctionFeb 25, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED INTERMITTENT SPO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11381997 ↗
• MalfunctionJan 27, 2021Sensing Intermittently; Material Separation; Sensing Intermittently; Material Separation

  THE CUSTOMER REPORTED THAT THE WIRE IS BARE AT THE CONNECTION AND MEASUREMENTS ARE INTERRUPTED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11236224 ↗
• MalfunctionJun 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE CABLE WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8664332 ↗
• MalfunctionDec 31, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED HAVING DIFFICULTIES OBTAINING SPO2 READINGS AND FLUCTUATIONS IN THE NUMBER. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207222 ↗
• MalfunctionJan 7, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "WAS TOLD BY RN (B)(6) THAT THE MONITOR IN ROOM 448 SPORADICALLY LOSES THE SPO2 READING. SHE CHANGED CABLES TWICE DURING HER SHIFT TO GET IT TO WORK. I HAVE THE 2 CABLES FROM THE SPECIFIC ROOM BUT NOT ANY SENSORS. AS TASKED BY LEADERSHIP, I AM TO PULL THE CABLE AND SEND IT FOR FAILURE ANALYSIS. UNFORTUNATELY THE RN DID NOT SAVE THE SENSOR. LOGS WERE PULLED AND I DIDN'T SEE ANY DROPOUTS, JUST LARGE DESATS." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170906 ↗
• MalfunctionJan 7, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "WAS TOLD BY RN HALEY THAT THE MONITOR IN ROOM 448 SPORADICALLY LOSES THE SPO2 READING. SHE CHANGED CABLES TWICE DURING HER SHIFT TO GET IT TO WORK. I HAVE THE 2 CABLES FROM THE SPECIFIC ROOM BUT NOT ANY SENSORS. AS TASKED BY LEADERSHIP, I AM TO PULL THE CABLE AND SEND IT FOR FAILURE ANALYSIS. UNFORTUNATELY THE RN DID NOT SAVE THE SENSOR. LOGS WERE PULLED AND I DIDN'T SEE ANY DROPOUTS, JUST LARGE DESATS." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170902 ↗