MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO XT; STRETCHER, WHEELED

Catalog Number	6506000000
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Laceration(s) (1946); Skin Tears (2516); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.9 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device is pending evaluation: evaluation results findings (components/results): 1 device: spring / dust or dirt problem identified.1 device: shock absorber / mechanical problem identified.3 devices: hydraulic system / mechanical problem identified.1 device: chassis/frame; rod/shaft / device migration.1 device: rod/shaft / wear problem.1 device: controller / device migration.1 device: shock absorber / device migration.1 device: appropriate term/code not available / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
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 10 malfunction event(s), where it was reported the device experienced unintended cot lowering or cot dropping to lowest position (no cot tip) or fowler unexpected drop/collapse.There were 2 events with patient involvement; 1 patient experienced a laceration and a skin tear, but no serious adverse consequence or clinically relevant delay in treatment was reported, and 1 it is unknown.
Event or Problem Description
This report now summarizes 9 malfunction event(s), instead of 10.
Additional Manufacturer Narrative
1 device that was originally coded as evaluated was found that there was no issue with the device.1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results) 1 device: chassis/frame/mechanical problem identified.

• Brand Name: POWER-PRO XT
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23393628
• Report Number: 0001831750-2025-99403
• Device Sequence Number: 18602980
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 7613327261639
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 9
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6506000000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown