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

Model Number	P3700E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that affinity 4 bed frame backrest would rise on its own as soon as it was plugged into the power outlet.The process step at which the issue occurred was not specified.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
E1 postal code: (b)(6).The baxter technician found the pcb needed to be replaced.The affinity 4 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 switches in the side rails to ensure they are functioning correctly.Also check for intermittent operation.A search of the baxter maintenance records showed baxter performed preventive maintenance on this bed feb 2026.It is unknown if the facility performed any other preventive maintenance on this bed.The technician replaced the pcb 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: 50027207
• Report Number: 1824206-2026-01697
• Device Sequence Number: 13396960
• Product Code: KNC
• UDI-Device Identifier: 00887761000896
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2026

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: P3700E
• Device Catalogue Number: P3700E000018
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2026
• Supplement Date Received by Manufacturer: 06/27/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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