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

Model Number	P3700E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nerve Damage (1979); Neuropathy (1983); Distress (2329); Hypoesthesia (2352); Ambulation or Postural Difficulties (2544)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury

• 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: 50148731
• Report Number: 1824206-2026-01815
• Device Sequence Number: 10708863
• Product Code: KNC
• UDI-Device Identifier: 00887761000896
• UDI-Public: (01)00887761000896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K915779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: P3700E
• Device Catalogue Number: P3700E000014
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown