MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX1-3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	3005S3PX1
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 4 malfunction event(s), where it was reported the device experienced accessible sharp edges exposed (metal).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.4 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results): 2 devices: cover / deformation problem, 1 device: ground strap/wire / fracture problem, 1 device: cover / fracture problem.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
This supplemental is being filed to include an additional results code following the completion of a device investigation.Evaluation results findings (components/results) 1 device: cover; weld/deformation problem.
Event or Problem Description
No new information.

• Brand Name: S3 PX1-3005
• 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: 23383712
• Report Number: 0001831750-2025-99267
• Device Sequence Number: 8644700
• Product Code: FNL
• UDI-Device Identifier: 07613327278378
• UDI-Public: 7613327278378
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• 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): 11/19/2025

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: 3005S3PX1
• 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: 11/19/2025
• 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