RD SET™ MD14-12 RD SET Series Patient Cable 4081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997009768), received between Mar 20, 2017 and Nov 10, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2017Device Stops Intermittently; Device Stops Intermittently

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023261 ↗
• MalfunctionMar 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT "CALL TODAY FROM (B)(6) , BIO-MED AT (B)(6). ASKED IF OUR SHIELDING OF THE RD CABLES IS THE SAME AS THE LNOP CABLE THEY PREVIOUSLY USED. THE NICU TRANSPORT TEAM SAID THE SP02 READING DROPPED OUT OR HAD PERIODIC READING WHEN THE HELICOPTER TAKES OFF AND WORKS FINE AS SOON AS THE HELICOPTER LANDS. THIS HAS OCCURRED ONLY ONCE THAT (B)(6) IS AWARE OF. THE MONITOR USED IN THE TRANSPORTER IS A WELCH ALLYN PROPAQ WITH A RD SET MD14 ¿ 12 CABLE. (B)(6) HAS TO DISMANTLE THE TRANSPORTER TO GET TO THE WELCH ALLYN MONITOR. HE SAID I COULD PICK UP THE CABLE ON THURS". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417137 ↗