MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6506 MTS PWRPRO COT MID CONFIG; STRETCHER, WHEELED

Catalog Number	650605550002
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	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.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 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.
Event or Problem Description
This report now summarizes 0 malfunction event(s), instead of 1.
Additional Manufacturer Narrative
It was reported that the device was having communication issues and getting stuck on the powerload.Upon communication with the field service representative and the user facility, it was confirmed that the issue was called in by mistake, and the work order was cancelled.The number of events summarized has been changed to 0, but the field is marked as 1 due to system requirements.

• Brand Name: 6506 MTS PWRPRO COT MID 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22608086
• Report Number: 0001831750-2025-99199
• Device Sequence Number: 9539380
• Product Code: FPO
• UDI-Device Identifier: 07613327513264
• UDI-Public: 7613327513264
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 11/19/2025

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: 650605550002
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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