S3 3005 (REF 3005S3EX)Recalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 07613327278309), received between Mar 23, 2018 and Jul 28, 2026 — classified as 2 deaths, 13 injuries, 227 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (43 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. How this data works · Data updated Oct 13, 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-2216-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Patient Device Interaction Problem

  Patient problems: Bruise/Contusion

  MAUDE report 50059653 ↗
• 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 6 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 24966969 ↗
• MalfunctionApr 23, 2026No Audible Alarm

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) - (B)(6) 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966492 ↗
• MalfunctionApr 23, 2026Device Fell

  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 FOWLER UNEXPECTED DROP/COLLAPSE OR IV POLE FALLS FROM UPRIGHT POSITION IN AN UNINTENDED DIRECTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966491 ↗
• MalfunctionJan 27, 2026Sharp Edges

  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 4 MALFUNCTION EVENT(S), 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 24187981 ↗
• MalfunctionJan 27, 2026No Audible Alarm

  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 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187978 ↗
• MalfunctionJan 27, 2026Device Fell

  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 LITTER/LIFT UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187844 ↗
• MalfunctionOct 24, 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 7 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 23383704 ↗
• MalfunctionOct 24, 2025No Audible Alarm; No Audible Alarm

  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 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383700 ↗
• MalfunctionOct 24, 2025Device Fell; Device Fell

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383692 ↗
• MalfunctionApr 28, 2025No Audible Alarm; No Audible Alarm

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT WITH A FALL; NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919632 ↗
• MalfunctionApr 28, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES 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 21919628 ↗
• MalfunctionApr 28, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INCORRECT MEASUREMENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919424 ↗
• MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES 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 21919400 ↗
• MalfunctionApr 28, 2025Grounding Malfunction; Grounding Malfunction

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED GROUND PATH COMPROMISED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919396 ↗
• MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 23 MALFUNCTION EVENTS, 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 21919393 ↗
• MalfunctionApr 28, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE OR SIDERAIL UNEXPECTED DROP/COLLAPSE . NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919390 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT OUT OF BED AND FELL RESULTING IN AN IMPACTED FRACTURE OF THE LEFT FEMORAL NECK. THE BED EXIT DID ALARM AS INTENDED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646799 ↗
• MalfunctionJan 30, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER COLLAPSE OR SIDERAIL COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273892 ↗
• MalfunctionJan 30, 2025No Audible Alarm; No Audible Alarm

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A FAILURE TO ALARM. IT WAS REPORTED THAT A PATIENT FELL AS A RESULT OF THE FAILURE TO ALARM.

  Patient problems: Fall

  MAUDE report 21273889 ↗
• MalfunctionJan 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT NOW SUMMARIZES 25 MALFUNCTION EVENTS, INSTEAD OF 26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246126 ↗
• MalfunctionJan 27, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INACCURATE SCALE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246124 ↗
• MalfunctionJan 27, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), 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 21246122 ↗
• MalfunctionOct 29, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INCORRECT MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556185 ↗
• MalfunctionOct 28, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549984 ↗