MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY LEX W/ ISOTOUR PREM; BED, AC POWERED ADJUSTABLE HOSPITAL

Catalog Number	3009PX-LEX-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient got out of the bed and fell.The nurse had not set the bed exit alarm.The patient was found with a neck injury though it is not confirmed at the time of reporting if the injury was a result of the fall.No product failure was alleged.
Event or Problem Description
No new info.
Additional Manufacturer Narrative
Further communication with the customer confirmed that the neck injury was pre-existing and not a result of the fall.This supplemental record is being submitted to clarify that no reportable adverse event occurred.

• Brand Name: PROCUITY LEX W/ ISOTOUR PREM
• Common Device Name: BED, AC POWERED ADJUSTABLE HOSPITAL
• 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: 22748455
• Report Number: 0001831750-2025-00719
• Device Sequence Number: 8716061
• Product Code: FNL
• UDI-Device Identifier: 07613327541236
• UDI-Public: (01)07613327541236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/25/2025

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: 3009PX-LEX-450
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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