MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Affinity 4 Birthing Bed; TABLE, OBSTETRIC (AND ACCESSORIES)

Model Number	P3700D
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that the affinity 4 bed frame had brakes not holding while in brake position.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the brake casters needed to be adjust.The affinity birthing bed requires an effective maintenance program.We recommend that you do annual preventive maintenance (pm) for joint commission certification.Pm not only meets joint commission requirements but can help make sure of a long, operative life for the affinity 4 birthing bed.Two effective ways to reduce downtime and make sure the patient remains comfortable are to keep accurate records and maintain the affinity 4 birthing bed.Check the tires for cuts, wear, tread life, etc.Apply the brake, and check to ensure that the bed will not move.If the bed moves, inspect it for wear, and adjust if required.Apply the steering pedal and check the steering to ensure proper locking action when activated.A search of the baxter maintenance records showed baxter performed preventive maintenance on this bed on feb, 2026.It is unknown if the facility performed any other preventive maintenance on this bed.The technician adjusted the brake casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: Affinity 4 Birthing Bed
• Common Device Name: TABLE, OBSTETRIC (AND ACCESSORIES)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50552657
• Report Number: 1824206-2026-02037
• Device Sequence Number: 13354478
• Product Code: KNC
• UDI-Device Identifier: 00887761000896
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CA
• PMA/510(K) Number: K915779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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
• Operator of Device: Other
• Device Model Number: P3700D
• Device Catalogue Number: P3700D000003
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2011
• 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