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

Catalog Number	3009PX-LE-400
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	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: sensor / failure to calibrate or used out of calibration.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 1 malfunction event(s), where it was reported the device experienced clinician not alerted/aware of possible patient fall.No adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: PROCUITY LE WITH ISOTOUR STD
• 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: 24187992
• Report Number: 0001831750-2026-99119
• Device Sequence Number: 9513811
• Product Code: FNL
• UDI-Device Identifier: 07613327541182
• UDI-Public: 7613327541182
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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-LE-400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/27/2026
• 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