RD SET™ MP-12 RD SET to IVM/MMS 4083Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843997009782), received between Nov 3, 2016 and Dec 2, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Sensing Intermittently; Sensing Intermittently

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919703 ↗
• MalfunctionAug 9, 2021High Readings; High Readings

  THE CUSTOMER REPORTED HEART RATE READINGS WERE HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298070 ↗
• MalfunctionAug 20, 2019Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED WHEN THE CABLE IS CONNECTED AND BEING USED THE SPO2 READINGS WERE STAYING IN THE 80S EVEN WHEN THE SENSOR WAS MOVED TO DIFFERENT SITES THE READINGS REMAINED IN THE 80S. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908943 ↗
• MalfunctionOct 12, 2018Sparking; Sparking

  THE CUSTOMER REPORTED THAT WHEN A SENSOR WAS PLUGGED INTO THE CABLE, THERE WAS A SPARK, AND THE CABLE HAS BURN MARKS ON IT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962341 ↗
• MalfunctionFeb 16, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED: "CABLE SPLITTING AT CASTING OF SENSOR CONNECTION END; THEREFORE CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND ISSUES OVERALL WITH MONITORING EFFECTIVELY AND ACCURATELY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7279229 ↗
• MalfunctionFeb 16, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "RD PHILIPS CABLE PART NUMBER 4083 SPLITTING AT CASING OF SENSOR CONNECTION END; THEREFORE CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND CAUSING ISSUES OVERALL WITH MONITORING EFFECTIVELY AND ACCURATELY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7279226 ↗
• MalfunctionFeb 16, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "RD PHILIPS CABLE PART NUMBER 4083 SPLITTING AT CASING OF SENSOR CONNECTION END; THEREFORE CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND CAUSING ISSUES OVERALL WITH MONITORING EFFECTIVELY AND ACCURATELY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7279225 ↗
• MalfunctionSep 22, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED CABLE WORKS INTERMITTENTLY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6888960 ↗
• MalfunctionSep 22, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED CABLE WORKS INTERMITTENTLY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6888955 ↗
• MalfunctionJun 30, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED CABLE WORKS INTERMITTENTLY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6683059 ↗
• MalfunctionMar 24, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE VALUE OF SP2 WAS LOW (45-90%). THE EVENT WAS NOT RESOLVED WITH THE REPLACEMENT. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6433992 ↗
• MalfunctionDec 2, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT LOOSE CONNECTION AT MONITOR PLUG. IF YOU MOVE THE CABLE AT THE ROUND PLUG, THERE IS SPORADICALLY NO MORE CURVE. PER THE CUSTOMER, THERE WAS A MEASUREMENT IN THE BEGINNING, BUT FURTHER ON THE ARTIFACTS INCREASED, THE MEASUREMENT DISAPPEARED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6141955 ↗
• MalfunctionNov 3, 2016Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED SEEING AN SPO2 OF 39% ON THE PATIENT WHICH DID NOT MATCH THE CLINICAL PICTURE WHEN USING A PHILIPS MP 50 WITH FAST VIA A MMS MODULE. REPLACING THE CABLE RESOLVED THE ISSUE. THESE FAILURES OCCURRED IN SIX BEDS IN A SMALL LONG TERM PEDIATRIC VENTILATOR UNIT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6075997 ↗