Prime Series 1105 (REF 1105-000-026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07613327278149), received between Sep 6, 2018 and Apr 22, 2026 — classified as 3 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (32 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. May 12, 2021Open, Classified

   Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

   Z-2207-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Device Slipped

  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 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES 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 24958643 ↗
• MalfunctionApr 22, 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 2 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 24958490 ↗
• 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 OCTOBER 1-DECEMBER 31, 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 24178847 ↗
• 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 (B)(6) 2025 - (B)(6) 2025. THIS REPORT SUMMARIZES 5 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 23392293 ↗
• 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 23392291 ↗
• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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 ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392146 ↗
• MalfunctionOct 27, 2025Device Slipped; Device Slipped

  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 - (B)(6) 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES, 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 23392143 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 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 21911994 ↗
• MalfunctionApr 25, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911952 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE 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 21911943 ↗
• MalfunctionApr 25, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910537 ↗
• MalfunctionJan 24, 2025Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULTY ENGAGING THE BRAKE OR STEER MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232969 ↗
• MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKS ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232887 ↗
• MalfunctionOct 25, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534143 ↗
• MalfunctionOct 25, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES CANNOT BE ENGAGED OR BRAKES DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533869 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533721 ↗
• MalfunctionJul 25, 2024Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828575 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 3 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 19828569 ↗
• MalfunctionApr 22, 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 19154710 ↗
• MalfunctionFeb 22, 2024Device Fell; Device Fell

  IT WAS REPORTED THAT THE SIDERAIL JOINT BROKE AND GAVE AWAY. IT WAS FURTHER REPORTED THAT A PATIENT FELL OUT OF THE STRETCHER ONTO THEIR HEAD. ATTEMPTS ARE BEING MADE TO GATHER POTENTIAL INJURY AND TREATMENT DETAILS FROM THE USER FACILITY.

  Patient problems: Fall

  MAUDE report 18762904 ↗
• MalfunctionJan 24, 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 18574357 ↗
• MalfunctionJan 24, 2024Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574347 ↗
• MalfunctionJan 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 8 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 18562787 ↗
• MalfunctionJan 23, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE OR BRAKES CANNOT BE ENGAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562785 ↗
• MalfunctionDec 12, 2023Difficult or Delayed Positioning; Mechanical Jam; Difficult or Delayed Positioning; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE HAS STIFFNESS/STEERING ISSUES. A STAFF MEMBER COMPLETED AN INCIDENT REPORT COMPLAINING OF BACK PAIN, WHICH CAUSED THEM TO TAKE SICK LEAVE DAYS. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 18310975 ↗