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

Catalog Number	3009PX-ZMX-450
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Fall (1848)
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 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
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.Evaluation results findings (components/results).1 device: appropriate term/code not available / no findings available.There was no remedial action taken.This device is not labeled for single use.

• Brand Name: PROCUITY ZMX WITH 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: 23384144
• Report Number: 0001831750-2025-99317
• Device Sequence Number: 8717808
• Product Code: FNL
• UDI-Device Identifier: 07613327541304
• UDI-Public: 7613327541304
• 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): 10/24/2025

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-ZMX-450
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/24/2025
• 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