MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER26INLITTER; STRETCHER, WHEELED, POWERED

Catalog Number	1125000026
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced zoom suddenly stops.There was 1 event with patient involvement; the patient experienced fatigue and pain.
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.There was no remedial action taken.This device is not labeled for single use.

• Brand Name: PRIME ZOOM STRETCHER26INLITTER
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17998621
• Report Number: 0001831750-2023-01262
• Device Sequence Number: 6669668
• Product Code: INK
• UDI-Device Identifier: 07613327278316
• UDI-Public: 07613327278316
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140095
• 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
• Report Date (Section B): 10/24/2023

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: 1125000026
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2023
• Initial Report FDA Received Date: 10/24/2023
• 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