Prime Series 1115 (REF 1115-000-026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 07613327278231), received between Apr 23, 2018 and Apr 23, 2026 — classified as 4 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (34 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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Mechanical Jam

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965132 ↗
• MalfunctionApr 23, 2026Sharp Edges

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965128 ↗
• MalfunctionJan 26, 2026Device Slipped

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS SLIDES OFF LITTER; UNSTABLE MATTRESS SUPPORT . NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180202 ↗
• MalfunctionJan 26, 2026Mechanical Jam

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178590 ↗
• MalfunctionOct 27, 2025Mechanical Jam; Mechanical Jam

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393622 ↗
• MalfunctionOct 27, 2025Sharp Edges; Sharp Edges

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393060 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912123 ↗
• MalfunctionApr 25, 2025Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 22 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE OR STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911580 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DO NOT REMAIN ENGAGED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911540 ↗
• MalfunctionJan 30, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FALSE LATCH OF THE SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273856 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKING ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241355 ↗
• MalfunctionJan 27, 2025Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES OR STEER MECHANISMS WHICH WERE DIFFICULT TO ENGAGE OR DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241352 ↗
• MalfunctionOct 29, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 16 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE, BRAKES DIFFICULT TO ENGAGE/DISENGAGE OR BRAKES CANNOT BE ENGAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558727 ↗
• MalfunctionOct 25, 2024Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538960 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832300 ↗
• MalfunctionJul 25, 2024Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832210 ↗
• MalfunctionJul 25, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES CANNOT BE ENGAGED OR STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832155 ↗
• MalfunctionJul 25, 2024Device Slipped; Device Slipped

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS SLIDES OFF LITTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832151 ↗
• MalfunctionApr 22, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE OR BRAKES CANNOT BE ENGAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156078 ↗
• MalfunctionApr 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155156 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154950 ↗
• MalfunctionJan 24, 2024Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576165 ↗
• MalfunctionJan 23, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563158 ↗
• MalfunctionJan 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563156 ↗
• MalfunctionOct 25, 2023Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007349 ↗