MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN; SUPPORT, PATIENT POSITION

Model Number	103001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the cflex head positioner.There was no allegation of patient or caregiver injury or death reported from this alleged incident.No further information is available on the repair of the bed at this time.The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
Baxter received a report stating that cflex polar head positioner was not holding the patients head in the lock position.The issue was discovered in the or after placing the patient in position.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The head positioner is designed to position and support the patient¿s head in a variety of surgical procedures including, but not limited to spine surgery.These devices are intended to be used by healthcare professionals within the operating room setting.The cflex head positioner was received by baxter.Upon inspection, it was found that there was an unwanted movement in the pivot.The pivot and the screws were adjusted.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a cflex head positioner having an unintended movement were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that cflex polar head positioner was not holding the patients head in the lock position.The issue was discovered in the or after placing the patient in position.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: ALLEN
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20810927
• Report Number: 3010216206-2024-00032
• Device Sequence Number: 9849472
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: (01)00615521002701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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
• Operator of Device: Health Professional
• Device Model Number: 103001
• Device Catalogue Number: A-70701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 04/26/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 05/05/2025
• 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