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

Catalog Number	1115000000X
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the scale was reading inaccurately on a stroke patient.The recorded weight was subsequently used to calculate and administer rt-pa, and due to the inaccurate reading, the patient received an excessive dose.As a result, the patient sustained an intracranial hemorrhage (brain bleed) and was transferred to a high dependency unit.At a later date, the patient was transferred to a normal ward to stabilize.

• Brand Name: BIG WHEEL 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: 24931226
• Report Number: 0001831750-2026-00031
• Device Sequence Number: 20172573
• Product Code: FPO
• UDI-Device Identifier: 07613327278248
• UDI-Public: (01)07613327278248
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 1115000000X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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