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

Catalog Number	3009PX-LEX-400
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the devices, experienced clinician not alerted/aware of possible patient fall.There was 1 event with patient involvement with 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.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
1 device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found.Section h codes have been updated to reflect this.
Event or Problem Description
No new information.

• Brand Name: PROCUITY LEX 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: 21919647
• Report Number: 0001831750-2025-00522
• Device Sequence Number: 9086905
• Product Code: FNL
• UDI-Device Identifier: 07613327541229
• UDI-Public: 07613327541229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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-LEX-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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