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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO MTS POWER LOAD; STRETCHER, WHEELED Back to Search Results
Catalog Number 639005550001
Medical Device Problem Code Device Fell (4014)
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 was functionally/visually inspected in the field.The device was repaired and returned to use.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 2 malfunction events(s), where it was reported the devices experienced fastener no longer facilitates proper cot operations during loading/unloading.No adverse consequence or clinically relevant delay in treatment was reported.
 
Additional Manufacturer Narrative
The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (results/components): 1 device: no findings available/appropriate term/code not available.
 
Event or Problem Description
No new information.
 
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Brand Name
MTS 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 Key22592687
Report Number0001831750-2025-99171
Device Sequence Number21120751
Product Code FPO
UDI-Device Identifier07613327394740
UDI-Public7613327394740
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Exemption NumberVMSR
Number of Events Summarized2
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) 09/18/2025
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 Number639005550001
Is the Reporter a Health Professional? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/01/2025
Supplement Date Received by Manufacturer07/01/2025
Initial Report FDA Received Date07/24/2025
Supplement Report FDA Received Date09/18/2025
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 Number1
Patient SexUnknown
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