MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	3005S3EX
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
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.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.1 device was not evaluated as the cause was determined by analyzing data provided by the user/third party; no further assistance was requested by the customer.1 device was not evaluated, as a probable cause for the issue was identified during communication between the customer and stryker and no further assistance was requested by the customer.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 6 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.
Event or Problem Description
This report now summarizes 5 malfunction events, instead of 6.
Additional Manufacturer Narrative
The device that was pending was evaluated and it was determined the device experienced ibed awareness cannot be activated, which is not reportable.Section h codes have been updated.

• Brand Name: S3 EX - 3005
• 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: 21919632
• Report Number: 0001831750-2025-00514
• Device Sequence Number: 18413617
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 5
• 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): 05/01/2025

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: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• 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: 05/01/2025
• 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