Medline MDS5001Recalls & reported problems
Medline Industries, Inc. · MONITOR,BP,AUTO,DIGITAL,UNIVERSAL · Class 2
- Adverse event reports
- 747
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 747 adverse event reports that list this exact device (DI 00888277675714), received between Nov 6, 2024 and Sep 30, 2026 — classified as 2 injuries, 742 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (404 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem404
- Incorrect, Inadequate or Imprecise Result or Readings119
- Unable to Obtain Readings101
- Inflation Problem65
- High Readings64
- Gas/Air Leak62
- Low Readings32
- Display or Visual Feedback Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions707
- Limb Pain11
- Discomfort9
- Pain7
- Bruise/Contusion6
- High Blood Pressure/ Hypertension5
- Numbness4
- Paresthesia3
Recent adverse event reports
The 25 most recent of 747 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955018 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954935 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954171 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953750 ↗MalfunctionSep 30, 2026No Display/Image; Unable to Obtain Readings; Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952572 ↗MalfunctionSep 30, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952374 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952348 ↗MalfunctionSep 30, 2026Computer Software Problem; Unable to Obtain Readings
It was reported that the device "WOULDNT EVEN START, KEEPS GIVING ER0, TRIED SEVERAL TIMES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952336 ↗MalfunctionSep 30, 2026Computer Software Problem
It was reported that "U2 ERROR, CUFF WILL NOT INFLATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952301 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952163 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952144 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951936 ↗MalfunctionSep 30, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951652 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951610 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951536 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951499 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951427 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951351 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951247 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951231 ↗MalfunctionSep 30, 2026Computer Software Problem
It was reported that the blood pressure monitor "never worked, it just shows \"ERROR\"" and the replacement "also doesn't work, showing \"ERROR\" or \"ERR\" when trying to take the blood pressure."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951214 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951213 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950814 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950002 ↗MalfunctionSep 30, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949980 ↗
Other System, measurement, blood-pressure, non-invasive devices
- Medline MDS4003Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive398 reports
- Medline MDS4001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive267 reports
- Medline MDS3001UMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive170 reports
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- DTX(TM) PLUS DT-4812 682000Argon Critical Care Systems Singapore Pte. Ltd. · System, Measurement, Blood-Pressure, Non-Invasive86 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 reports
- Acumen IQ Cuff Adult AIQCAEdwards Lifesciences LLC · System, Measurement, Blood-Pressure, Non-Invasive64 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.