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	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 (b)(6) ¿ (b)(6) 2026.This report summarizes 3 malfunction events(s), where it was reported the devices experienced clinician not alerted/aware of possible patient fall condition.There were 2 events with patient involvement; the patients experienced a fall.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.Evaluation results findings (components/results).1 device: plug / device migration.2 devices are pending evaluation.Evaluation results findings (components/results).2 devices: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.

• 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: 24966927
• Report Number: 0001831750-2026-99244
• Device Sequence Number: 18786641
• 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: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• 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