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

Catalog Number	6390000000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The 1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found.
Event or Problem Description
No new information.

• Brand Name: POWER LOAD
• 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: 21276326
• Report Number: 0001831750-2025-00290
• Device Sequence Number: 3627262
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 05/30/2025

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: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 01/01/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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