MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS C-FLEX POLAR HEAD POSITNR- DEVICE ONLY; SUPPORT, PATIENT POSITION

Model Number	A-70701
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the allen c-flex head positioner allegedly caused a pressure injury to a patient¿s chin.There was no allegation of a device malfunction reported.On (b)(6) 2023, the c-flex was used during a posterior cervical case with a mizuho face mask pad and mizuho face plate.The customer was sent baxter/allen disposable face masks, however, the baxter sales representative who was present at the time of the surgery did not recall seeing them or that they were used with the c-flex.On (b)(6) 2023, the customer reported to the baxter sales representative that when the patient was taken out of the positioner, he had developed a severe pressure injury on his chin.The customer was uncertain how this happened, but stated the patient was in a prone position for 9 plus hours.Additionally, the baxter sales representative stated the patient was placed in trendelenburg at some point for the surgery itself and imaging; however, the customer denied this.The baxter sales representative also noted a lot of surgical tape was used to position the patient and limit movement.Attempts to obtain additional information including but not limited to the stage of the pressure injury, treatment, relevant medical history, and outcome have been unsuccessful.This incident has been captured under hillrom complaint ref#: (b)(4).
Additional Manufacturer Narrative
The c-flex polar head positioner is used in a variety of surgical procedures including, but not limited to spine surgery.These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.A review of the device instructions for use (ifu) found the mizuho face mask and face plate are not listed as compatible products with the c-flex polar head positioner.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface.Pressure injuries can develop within 2-6 hours when capillaries supplying the skin and subcutaneous tissues are compressed, causing an obstruction in blood flow, which ultimately leads to tissue necrosis.Position changes are key to pressure injury prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.Prevention of pressure injuries involves a multidisciplinary approach including rapid identification of at-risk individuals such as those with diabetes, incontinence, impaired mobility, peripheral vascular disease, etc., and exercising a vigilant prevention protocol consisting of skincare, nutritional assessment reducing mechanical load, and utilizing support surfaces.In this event, the patient reportedly developed a severe pressure injury on the chin after being in prone position during a 9-hour posterior cervical case in which the c-flex head positioner was used.The customer did not provide the necessary information to determine the severity of the event and attempts to obtain additional clinical information from the customer have been unsuccessful.There was no report of medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure at the time of the initial report.Based on the limited details provided, the severity of the injury is unable to be determined at this time.The cause of the event is undetermined; however, use error cannot be ruled out as a contributing factor as it was noted products were used that are not listed as being compatible with the c-flex polar head positioner in the device ifu in addition to use of a large amount of surgical tape.There was no allegation of a device malfunction.Hillrom is cautiously reporting this event.

• Brand Name: C-FLEX POLAR HEAD POSITNR- DEVICE ONLY
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18416043
• Report Number: 3010216206-2023-00007
• Device Sequence Number: 20800221
• Product Code: CCX
• UDI-Device Identifier: 00615521002701
• UDI-Public: 615521002701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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
• Device Model Number: A-70701
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male