Power-LOAD 6390 (REF 6390-000-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 07613327261523), received between Feb 16, 2018 and Apr 23, 2026 — classified as 3 deaths, 18 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Device Fell” (47 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 124 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 2 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 24967216 ↗
• MalfunctionOct 27, 2025Device Dislodged or Dislocated; Device 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 JULY 1- SEPTEMBER 30, 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 23393823 ↗
• MalfunctionOct 27, 2025Device Fell; Device Fell

  NO NEW INFORMATION.

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

  MAUDE report 23393421 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE RAISED THE COT AND THEN DROPPED IT. AS A RESULT, THE USER INJURED A BICEP AND HAD TO HAVE SURGERY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23373011 ↗
• MalfunctionOct 10, 2025Fire; Fire

  IT WAS REPORTED THAT THERE WAS A 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 23267418 ↗
• MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 8 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 21922045 ↗
• MalfunctionApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, 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 21921719 ↗
• MalfunctionApr 28, 2025Device 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 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 21919821 ↗
• MalfunctionJan 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A PINCH/CRUSH POINT. THIS ALLEGEDLY LED TO A MINOR INJURY TO A STAFF MEMBER IN THE FORM OF A LACERATION.

  Patient problems: Laceration(s)

  MAUDE report 21276326 ↗
• MalfunctionJan 30, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A FAILURE OF THE FASTENER TO FACILITATE PROPER COT OPERATIONS DURING LOADING OR UNLOADING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275772 ↗
• MalfunctionJan 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 6 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 21257414 ↗
• MalfunctionOct 29, 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 20560518 ↗
• MalfunctionOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FASTENER UNEXPECTEDLY DISENGAGES/ FALSE ENGAGEMENT INTO FASTENER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556627 ↗
• MalfunctionOct 29, 2024Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 5 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 20556597 ↗
• MalfunctionJul 29, 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 19850338 ↗
• MalfunctionJul 26, 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 19843397 ↗
• 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 19843302 ↗
• MalfunctionJun 18, 2024Device Fell; Device Fell

  IT WAS REPORTED THAT THE DEVICE USER EXPERIENCED A COMPLETE POWER LOAD HYDRAULIC FAILURE WHILE LOADING A PATIENT INTO THE BACK OF AN AMBULANCE. THIS FAILURE CAUSED THE POWER LOAD AND STRETCHER (XT) TO GIVE WAY. FORTUNATELY, THE CREW MANAGED TO SUPPORT THE STRETCHER, PREVENTING THE PATIENT FROM FALLING TO THE FLOOR. ALTHOUGH THE PATIENT WAS UNINJURED, THE CREW EXPERIENCED SOME STRAIN ON THEIR BACKS.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19560619 ↗
• MalfunctionJun 3, 2024Device Fell; Device Fell

  IT WAS REPORTED THAT THE DEVICE DROPPED THE COT DURING LOADING, WHICH RESULTED IN THE CAREGIVER HURTING THEIR HAND. THE CUSTOMER REPORTED THAT THERE WAS NOT A SIGNIFICANT INJURY FROM THIS EVENT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19454679 ↗
• MalfunctionApr 29, 2024Device Fell; Device Fell

  IT WAS REPORTED THAT THE SCREWS ON THE DEVICE'S WHEELS SNAPPED AND CAUSED THE COT TO FALL DOWN TO THE GROUND. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT FELL OFF OF THE COT AND WAS INJURED.

  Patient problems: Abrasion; Hematoma; Insufficient Information

  MAUDE report 19209313 ↗
• MalfunctionApr 23, 2024Sharp 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 19162975 ↗
• MalfunctionApr 23, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, 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. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED ANXIETY AND PAIN.

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

  MAUDE report 19162969 ↗
• InjuryApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER WILL HAVE TO HAVE A PARTIAL AMPUTATION OF A FINGER. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19101275 ↗
• MalfunctionJan 24, 2024Patient Device Interaction Problem; Device Fell; Patient Device Interaction Problem; 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 AND PINCH/CRUSH POINT. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574533 ↗
• 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 18573187 ↗

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.