MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PERFORMANCELOAD; STRET

Catalog Number	6392000004
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damaged components on the performance load caused the cot to tip during unloading (fastener no longer facilitates proper cot operations during loading/unloading).There was a patient on the cot at the time and they were transported to hospital to be evaluated for non-specified injuries.No adverse consequence was alleged to have occurred to the staff unloading the cot at the time of the incident.

• Brand Name: PERFORMANCELOAD
• Common Device Name: STRET
• 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: 19082317
• Report Number: 0001831750-2024-00359
• Device Sequence Number: 8248641
• Product Code: FPO
• UDI-Device Identifier: 07613327282610
• UDI-Public: 07613327282610
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/10/2024

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: 6392000004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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