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	No Audible Alarm (1019)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device(s) was/were functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results) 1 device: cable; electrical / electrical/electronic component problem identified.1 device was not evaluated, as a probable cause for the issue was identified during communication between the customer and stryker and no further assistance was requested by the customer; no defect or malfunction was found.Evaluation results findings (components/results) 1 device: appropriate term/code not available / no device problem found.1 device was not evaluated as the cause was determined by analyzing data provided by the user/third party; no further assistance was requested by the customer; no defect or malfunction was found.Evaluation results findings (components/results) 1 device: alarm / no device problem found.1 device is pending evaluation.Evaluation results findings (components/results) 1 device: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1-december 31, 2025.This report summarizes 4 malfunction event(s), where it was reported the device experienced clinician not alerted/aware of possible patient fall.There were 2 events with patient involvement; 1 patient experienced a fall and an abrasion, 1 patient experienced a fall.
Additional Manufacturer Narrative
The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results) 1 device: appropriate term/code not available/no findings available.
Event or Problem Description
No new information.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 24189122
• Report Number: 0001831750-2026-99123
• Device Sequence Number: 8009923
• Product Code: FNL
• UDI-Device Identifier: 07613327541236
• UDI-Public: 7613327541236
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 3009PX-LEX-450
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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