MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN FLEX FRAME; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	A-70100
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).Baxter is in the process of inspecting the allen flex frame.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 allen flex frame hydraulic support rod of the spine brace was shaking.The bed was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The flex frame is designed to position and support the patient¿s head, chest, arms, abdomen and hip in a variety of surgical procedures including, but not limited to spine, cranial, cervical surgery and/or surgery that requires prone, lateral and supine positioning.These devices are intended to be used by healthcare professionals within the operating room setting.Per the ifu, the base joint can be locked usng the foot pedals.When the lock is depressed it applies drag to the ball joint, which helps stabilize the leg.To prevent patient and/or user injury and/or equipment damage, verify the device attaching clamps completely touch the table-side rails and are firmly in place.Test the locking mechanism to ensure no movement when elevated or pushed.According with the service notes the technician has inspected the reported issue on site, the equipment¿s locking function was normal and no fault was found.Based on this information, no further action is required.The reported event of hydraulic support rod of the spine brace shaking is likely to cause or contribute death or serious injury, and could be contributed to a user error due to end user failing to lock the rotation during clinical use.Prevention of this type of event is outlined per the ifu as mentioned above.Therefore, baxter considers this event reportable to the fda.
Event or Problem Description
Baxter received a report stating that allen flex frame hydraulic support rod of the spine brace was shaking.The bed was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: ALLEN FLEX FRAME
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• 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: 21044494
• Report Number: 3010216206-2024-00035
• Device Sequence Number: 7595644
• Product Code: FWZ
• UDI-Device Identifier: 00615521002176
• UDI-Public: (01)00615521002176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/16/2025

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: A-70100
• Device Catalogue Number: A-70100
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/16/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown