Power-LOAD 639005550003Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327504453), received between Oct 28, 2020 and Apr 23, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device Fell” (11 reports).

3 other recalls cover devices cleared under the same FDA submission (K113598); they may or may not involve this specific model.

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967393 ↗
• MalfunctionJan 26, 2026Device Dislodged or Dislocated

  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 FASTENER UNEXPECTEDLY DISENGAGES/ FALSE ENGAGEMENT INTO FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177458 ↗
• MalfunctionOct 27, 2025Device Fell; Device Fell

  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 EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT THAT EXPERIENCED PAIN.

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

  MAUDE report 23393833 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), 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 22592713 ↗
• MalfunctionJul 24, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592686 ↗
• MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 3 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 21921715 ↗
• MalfunctionJan 28, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE FASTENER NO LONGER FACILITATING PROPER COT OPERATIONS DURING LOADING OR UNLOADING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257419 ↗
• MalfunctionJan 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257417 ↗
• MalfunctionJul 26, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED MUSCLE/TENDON DAMAGE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19843786 ↗
• MalfunctionApr 23, 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 19163103 ↗
• MalfunctionApr 23, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162977 ↗
• MalfunctionJan 24, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573183 ↗
• MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER UNEXPECTEDLY DISENGAGES. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997632 ↗
• MalfunctionOct 24, 2023Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997622 ↗
• MalfunctionOct 24, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997616 ↗
• MalfunctionJul 24, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376871 ↗
• MalfunctionApr 25, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE FASTENER NO LONGER FACILITATED PROPER COT OPERATION DURING LOADING AND UNLOADING. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER AN EMT EXPERIENCED A MINOR INJURY AS A RESULT WHICH DID NOT REQUIRE TREATMENT.

  Patient problems: Pain

  MAUDE report 16807240 ↗
• MalfunctionApr 25, 2023Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807237 ↗
• MalfunctionJan 19, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210613 ↗
• MalfunctionApr 26, 2022Sharp Edges; Sharp Edges

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207238 ↗
• MalfunctionSep 23, 2021Difficult or Delayed Positioning; Patient-Device Incompatibility; Difficult or Delayed Positioning; Patient-Device Incompatibility

  IT WAS REPORTED THAT TWO EMPLOYEES EXPERIENCED PINCHED FINGERS WHILE HAVING DIFFICULTY TRYING TO UNLOAD A COT FROM THE POWERLOAD. NO SERIOUS INJURY WAS ALLEGED TO HAVE OCCURRED AS A RESULT OF THE PINCHING.

  Patient problems: Pain

  MAUDE report 12520728 ↗
• MalfunctionJul 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DISENGAGEMENT OF THE FASTENER. THERE WAS PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233838 ↗
• MalfunctionFeb 5, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THE DEVICE HAD ACCESSIBLE SHARP METAL EDGES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287024 ↗
• MalfunctionOct 28, 2020Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE FASTENER DROPPED THE COT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10747654 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113598. One submission often covers many models, so check the product and lot details in each record.

• Z-1350-2019 · Nov 20, 2018 · Terminated
  Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
• Z-1389-2018 · Mar 12, 2018 · Terminated
  Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretc
• Z-0566-2013 · Oct 11, 2012 · Terminated
  The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.