MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Catalog Number	650705550001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/20/2026
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
Please see updated b5 section for executive summary.
Event or Problem Description
On (b)(6) 2026, a risk assessment was conducted with input from risk management, regulatory affairs, and quality representatives to evaluate the extent of potential injury, as no response had been received from the customer following three contact attempts.Based on the available information at that time, there was insufficient evidence to establish that the reported delay caused or contributed to the alleged death.Additionally, a product evaluation concluded that no product malfunction was identified that may have contributed to the reported delay.On (b)(6) 2026, a clinical assessment was conducted with a sr.Manager, clinical affairs, to further evaluate whether the reported delay may have caused or contributed to the alleged death.Based on the available clinical information, the product evaluation, and the intended use of the device, there is no evidence to support that the power-pro 2 system caused or contributed to the patient's adverse clinical outcome (death due to myocardial infarction).The reported issue describes an inability to load the cot electrically into the power-load system, which represents an operational or use-related limitation, not a malfunction that directly impacts patient physiology.Importantly, the power-pro 2 cot is designed with a manual loading capability, which serves as a standard backup method.The patient could have been safely loaded and transported using this manual process.There is no causal mechanism by which the loading system could induce or contribute to a myocardial infarction.The underlying cause of death (heart attack) is a medical event unrelated to the function of the cot or loading system.While the need to request a second transport unit may have introduced a delay, there is insufficient information to establish that any delay was clinically significant or that it contributed to the fatal outcome.Conclusion: the device function (inability to load electrically) did not directly or indirectly cause or contribute to the patient¿s heart attack or death.The event is most consistent with an unrelated medical condition, and the device performed within its intended risk profile given the availability of manual backup procedures.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 24393943
• Report Number: 0001831750-2026-00013
• Device Sequence Number: 20974771
• Product Code: FPO
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 650705550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown