MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ZOOM STRETCHER, PRIME X; STRETCHER, WHEELED, POWERED

Catalog Number	1125000000X
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 (b)(6) 2025.This report summarizes 1 malfunction event(s), where it was reported the device experienced the litter detaching.There was a user involved that had a fall, but unlcear at this time if there was an adverse event.
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.Evaluation results findings (components/results) 1 device: insufficient information / results pending completion of investigation there was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The device that was pending was determined upon completion of the investigation that the device experienced litter is loose/wobbly, which is not reportable.The number of events summarized has been changed to 0, but the field is marked as 1 due to system requirements.
Event or Problem Description
This report now summarizes 0 malfunction event(s), instead of 1.

• Brand Name: ZOOM STRETCHER, PRIME X
• Common Device Name: STRETCHER, WHEELED, POWERED
• 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: 24183378
• Report Number: 0001831750-2026-99071
• Device Sequence Number: 18567612
• Product Code: INK
• UDI-Device Identifier: 07613327278323
• UDI-Public: 7613327278323
• 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): 04/03/2026

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: 1125000000X
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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