Power-PRO 2, High Configuration 650705550001Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07613327559118), received between Jul 26, 2022 and Apr 22, 2026 — classified as 2 deaths, 97 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (25 reports).

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. May 24, 2023Class IIOpen, Classified

   Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.

   Z-2130-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 1, 2023Class IIOpen, Classified

   Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

   Z-1256-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Difficult or Delayed Positioning; Device 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 COT TIP OR DROP (DURING LOAD/UNLOAD) AND DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958484 ↗
• MalfunctionApr 22, 2026Protective Measures Problem

  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 INADEQUATE PATIENT RESTRAINT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958481 ↗
• MalfunctionApr 22, 2026Difficult to Remove

  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 7 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958479 ↗
• MalfunctionApr 22, 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 COT TIP OR DROP (DURING LOAD/UNLOAD). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958404 ↗
• MalfunctionApr 22, 2026Difficult or Delayed Positioning; 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 JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE AND COT FALSELY ENGAGES INTO FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958382 ↗
• MalfunctionApr 22, 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 JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED COT FALSELY ENGAGES INTO FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958374 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE LOADED INTO THE POWER LOAD. THE DEPARTMENT REQUESTED A 2ND RESCUE TO TRANSPORT. IT WAS FURTHER REPORTED THAT THE PATIENT DIED OF A HEART ATTACK.

  Patient problems: Cardiac Arrest

  MAUDE report 24393943 ↗
• MalfunctionJan 28, 2026Difficult or Delayed Positioning

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199653 ↗
• MalfunctionJan 26, 2026Protective Measures Problem

  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 6 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INADEQUATE PATIENT RESTRAINT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183348 ↗
• MalfunctionJan 26, 2026Positioning Failure

  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) 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL; INADEQUATE SIDERAIL SUPPORT FORCE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183150 ↗
• MalfunctionJan 26, 2026Patient Device Interaction Problem

  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 PINCH/CRUSH POINT. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; IT IS UNKNOWN AT THIS TIME WHAT THE PATIENT EXPERIENCED.

  Patient problems: Discomfort; Insufficient Information; Pain

  MAUDE report 24183141 ↗
• MalfunctionJan 26, 2026Difficult to Remove

  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 INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182917 ↗
• MalfunctionJan 26, 2026Device Tipped Over

  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 COT TIP OR DROP (DURING LOAD/UNLOAD). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178588 ↗
• MalfunctionJan 26, 2026Difficult or Delayed Positioning; Difficult to Remove

  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 INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER AND DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS A PATIENT FALL, BUT NO SERIOUS ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178587 ↗
• MalfunctionJan 26, 2026Difficult or Delayed Positioning; Device Fell

  THIS REPORT ORIGINALLY SUMMARIZED 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE AND COT TIP OR DROP. AFTER FURTHER EVALUATION, IT WAS FOUND THAT THE DEVICE WAS NOT DIFFICULT TO LOAD/UNLOAD AND ONLY EXPERIENCED UNINTENDED COT LOWERING OR DROPPING; NO TIP (COT DROP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178584 ↗
• DeathDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN AMBULANCE ACCIDENT. THE PATIENT BEING TRANSPORTED PASSED AWAY AS A RESULT OF INJURIES SUSTAINED IN THE CRASH. THE CORONER'S OFFICE BELIEVES THE COT RESTRAINTS MAY HAVE CONTRIBUTED TO THE PATIENT¿S INJURIES, BUT THIS HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 23881840 ↗
• MalfunctionOct 24, 2025Protective Measures Problem; Protective Measures 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 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INADEQUATE PATIENT RESTRAINT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384017 ↗
• MalfunctionOct 24, 2025Difficult to Remove; Difficult to Remove

  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 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383863 ↗
• MalfunctionOct 24, 2025Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  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 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE AND FALSE ENGAGEMENT OF HANDLE IN THE UPRIGHT OR HORIZONTAL POSITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383858 ↗
• MalfunctionOct 24, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 44 MALFUNCTION EVENT(S), INSTEAD OF 45.

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

  MAUDE report 23383853 ↗
• MalfunctionOct 24, 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 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED COT TIP OR DROP (DURING LOAD/UNLOAD). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383845 ↗
• MalfunctionOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383718 ↗
• MalfunctionJul 25, 2025Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE AND FALSE ENGAGEMENT OF HANDLE IN THE UPRIGHT OR HORIZONTAL POSITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620737 ↗
• MalfunctionJul 25, 2025Difficult to Remove; Difficult to Remove

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608307 ↗
• MalfunctionJul 25, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 125 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FALSE ENGAGEMENT OF HANDLE IN THE UPRIGHT OR HORIZONTAL POSITION. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED DISCOMFORT.

  Patient problems: Discomfort; Muscle/Tendon Damage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608285 ↗