MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS ALLEN LIFT ASSIST BEACH CHAIR; SUPPORT, PATIENT POSITION

Model Number	A-91501
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer initially reported that the beach chair's support broke during surgery, the sterile field was compromised, and the patient was exposed to cross contamination.There was no allegation of patient or caregiver injury as a result of this event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The customer initially reported that the beach chair's support broke during surgery, the sterile field was compromised, and the patient was exposed to cross contamination.There was no allegation of patient or caregiver injury as a result of this event.The beach chair shoulder positioner is designed to position and support the patient¿s head and torso in a variety of surgical procedures including, but not limited to orthopaedic surgeries like, rotator cuff, total shoulder, reverse total shoulder, slap repair and other shoulder surgery.These devices are intended to be used by healthcare professionals within the operating room setting.This device is intended to be used with patients that do not exceed the safe working load of 500 lbs (226 kg).It is recommended to not apply excessive force to shoulder panel (61 lbs (27 kg) weight limit).During a follow-up call the customer confirmed the center of the beach chair's support cracked and the patient slid slightly to the left but did not fall.It was noted that the surgical team supported the beach chair using tape and was able to complete the case without further complication.It was also confirmed there was no injury, no contamination of the sterile field and the patient was not exposed to cross-contamination.The customer examined the device and stated they were unable to determine if the event was caused by wear and tear of the device or a weight limit issue.However, the customer could not provide the patient's weight.Although the customer confirmed there was no injury, no contamination of the sterile field and the patient was not exposed to cross-contamination, if a similar malfunction had to recur it would likely lead to a serious injury or death.The root cause of the reported malfunction was not yet determined.An inspection of the device is currently being arranged, all additional and relevant information that is identified following completion of the inspection will be submitted in a final report.
Event or Problem Description
The customer initially reported that the beach chair's support broke during surgery.There was no allegation of patient or caregiver injury as a result of this event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Upon technician inspection, the reported event was confirmed as backboard was found broken as it showed signs of abuse.The technician replaced the backboard in to resolve the reported event.Although the customer confirmed there was no injury, no contamination of the sterile field and the patient was not exposed to cross-contamination, if a similar malfunction had to recur it would likely lead to a serious injury or death.Therefore, baxter considers this event reportable.Based on this information, no further action is required.

• Brand Name: ALLEN LIFT ASSIST BEACH CHAIR
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17072908
• Report Number: 3010216206-2023-00003
• Device Sequence Number: 14976026
• Product Code: CCX
• UDI-Device Identifier: 00615521004125
• UDI-Public: 615521004125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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
• Device Model Number: A-91501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 11/14/2023
• 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