Power-LOAD 6390 (REF 639005550001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613327394740), received between May 10, 2019 and Apr 23, 2026 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Device Fell” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 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 3 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 24967218 ↗
• MalfunctionJan 26, 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 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 24177663 ↗
• 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 24177231 ↗
• 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 1 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; IT WAS NOT KNOWN WHAT THE PATIENT EXPERIENCED.

  Patient problems: Insufficient Information

  MAUDE report 23393831 ↗
• MalfunctionOct 10, 2025Fire; Smoking; Fire; Smoking

  IT WAS REPORTED THAT THE DEVICE'S BATTERY COMPARTMENT MAY HAVE CAUGHT ON FIRE. 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 23267440 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 13 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 22592715 ↗
• MalfunctionJul 24, 2025Device Fell; Device Fell

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592687 ↗
• MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 10 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 21921786 ↗
• MalfunctionApr 28, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED UNSPECIFIED MUSCULOSKELETAL PROBLEM.

  Patient problems: Muscle Weakness/Atrophy; Muscle/Tendon Damage; No Clinical Signs, Symptoms or Conditions; Numbness; Pain; Unspecified Musculoskeletal problem

  MAUDE report 21921722 ↗
• MalfunctionApr 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED PINCH/CRUSH POINT. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21919957 ↗
• MalfunctionJan 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 7 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 21257418 ↗
• MalfunctionOct 29, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 7 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 20556568 ↗
• MalfunctionJul 26, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES, EXPERIENCED FASTENER NO LONGER FACILITATES PROPER COT OPERATIONS DURING LOADING/UNLOADING. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED UNSPECIFIED MUSCULOSKELETAL PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Musculoskeletal problem

  MAUDE report 19843324 ↗
• MalfunctionJul 26, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 6 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 19843316 ↗
• MalfunctionApr 23, 2024Device 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 NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163290 ↗
• 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 19162971 ↗
• MalfunctionJan 24, 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 NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574547 ↗
• MalfunctionJan 24, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 4 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 18573178 ↗
• MalfunctionOct 24, 2023Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 3 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 17997629 ↗
• MalfunctionOct 24, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES 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 17997628 ↗
• MalfunctionOct 11, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT THE DEVICE FAILED TO ENGAGE, WHICH RESULTED IN A SPRAINED WRIST. THE DEVICE WAS TURNED BACK ON MANUALLY, BUT THEN THE ISSUE REOCCURRED ONCE THEY GOT TO THE HOSPITAL WITH A PATIENT ON THE DEVICE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17915952 ↗
• MalfunctionJul 18, 2023Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 4 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 17343404 ↗
• MalfunctionApr 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE ENGAGEMENT INTO THE FASTENER. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT THOUGH NO ADVERSE EVENT WAS ALLEGED TO HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807372 ↗
• MalfunctionApr 25, 2023Sharp 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 16807296 ↗
• MalfunctionJan 31, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT A BARIATRIC PATIENT WAS LOADED ON A COT AND WHILE BEING LOADED INTO THE AMBULANCE, THE POWER LOAD DROPPED THE COT AND AN EMPLOYEE INJURED THEIR BACK. FURTHER INFORMATION REGARDING THE INJURY WAS NOT PROVIDED.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 16272596 ↗

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.