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

Catalog Number	639005550001
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed to engage, which resulted in a work related injury.The device was turned back on manually, but then the issue reoccurred once they got to the hospital with a patient on the device.Attempts are being made to gather additional details from the user facility.
Event or Problem Description
It was reported that the device failed to engage, which resulted in a sprained wrist.The device was turned back on manually, but then the issue reoccurred once they got to the hospital with a patient on the device.
Additional Manufacturer Narrative
A visual and functional inspection was performed by a stryker field service technician.It was found that the fastener no longer facilitates proper cot operations during loading /unloading was likely not due to any defects.This alleged issue was likely due to user error.The issue was resolved for the customer by verifying functionality of the unit and ensuring nothing else was needed from stryker at this time.It was reported by (b)(6) that allegedly the power load system failed to engage the cot resulting in the work-related injury.In response to the alleged injury, a stryker quality assurance engineer contacted a executive director (b)(6) for further information regarding the caregiver injury.The caregiver strained their wrist and received ice as a treatment and went to two doctor appointments; no work was missed.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17915952
• Report Number: 0001831750-2023-01023
• Device Sequence Number: 17801281
• Product Code: FPO
• UDI-Device Identifier: 07613327394740
• UDI-Public: 07613327394740
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 639005550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown