MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY; BED, AC-POWERED ADJUSTABLE HOSPITAL,

Catalog Number	300900000000
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged that a patient fell out of bed and the bed alarm did not alert.It was reported that the patient sustained a pelvic fracture that was treated with surgery.
Additional Manufacturer Narrative
A visual and functional inspection was performed by a field service representative.It was found that the alleged issue of the bed alarm not alerting could not be recreated or duplicated.No parts were replaced, and the unit was returned to service.

• Brand Name: PROCUITY
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 25895807
• Report Number: 0001831750-2026-00049
• Device Sequence Number: 9893330
• Product Code: FNL
• UDI-Device Identifier: 07613327512656
• UDI-Public: 07613327512656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/21/2026

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?: No
• Device Catalogue Number: 300900000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: Required Intervention
• Patient Sex: Unknown