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	Fall (1848)
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 is pending evaluation.Evaluation results findings (components/results) 1 device: appropriate term/code not available / 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 july 1-september 30, 2025.This report summarizes 1 malfunction events(s), where it was reported the devices experienced clinician not alerted/aware of possible patient fall condition.There was 1 event with patient involvement that experienced a fall; no adverse consequences were reported.
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 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: 23384018
• Report Number: 0001831750-2025-99298
• Device Sequence Number: 8718293
• 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,Followup
• Report Date (Section B): 12/23/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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