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Sensica UO SCCS-1001Recalls & reported problems

Adaptec Medical Devices LLC · Automated urine meter system for continuous monitoring of urine output · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00854003008002), received between May 28, 2020 and Jun 26, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Inadequate or Insufficient Training” (4 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

Device problems

  • Inadequate or Insufficient Training4
  • Defective Device3
  • Break2
  • Appropriate Device Problem Term/Code Not Available1
  • Computer Operating System Problem1
  • Defective Component1
  • Therapeutic or Diagnostic Output Failure1
  • Use of Device Problem1

Patient problems

  • No Known Impact Or Consequence To Patient7
  • No Patient Involvement5

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 26, 2020Inadequate or Insufficient Training; Break; Inadequate or Insufficient Training

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL BROKEN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10201246 ↗
  • MalfunctionJun 25, 2020Use of Device Problem; Break; Use of Device Problem

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD DAMAGED PINS. THE BIOMED PEOPLE STATED THEY WILL SEND THE DEVICE IN FOR A QUALITY CHECK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10194624 ↗
  • MalfunctionJun 7, 2020Defective Component; Defective Component; Defective Device

    IT WAS REPORTED THAT THERE WAS A LOAD CELL ISSUE IN THE SENSICA DEVICE. PER FOLLOW UP ON 27MAY2020, BIOMED PEOPLE STATED THAT THEY REPLACED THE LOAD CELL AND DISCARDED IT. THE DEVICE CURRENTLY IN SERVICE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 10126636 ↗
  • MalfunctionMay 28, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training; Defective Device

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 10095856 ↗
  • MalfunctionMay 28, 2020Computer Operating System Problem; Computer Operating System Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 10095855 ↗
  • MalfunctionMay 28, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training; Defective Device

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 10095853 ↗
  • MalfunctionMay 28, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training; Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 10095852 ↗

Other Urinometer, Electrical devices

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Sources and updates

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