MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS ALLEN ADVANCE CHEST SUPPORT W/PAD; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	A-71301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a surgical procedure using the allen surgical table, the table¿s chest support base broke causing the patient to fall.It was reported that the patient was injured, however, specific details of the injury and any required intervention was not provided.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
During a follow-up call with the customer, the customer stated that there was no immediate injury to the patient, and no immediate intervention was required at the time of the event.The customer also reported that they are awaiting a final evaluation of injury report from the surgeon who performed the patient's surgical procedure at the time of the event.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
The customer reported that during a surgical procedure using the allen surgical table, the table¿s chest support base broke causing the patient to fall.It was reported that the patient was injured, however, specific details of the injury and any required intervention was not provided.This report was filed in our complaint handling system as (b)(6).
Additional Manufacturer Narrative
The customer reported that during a surgical procedure using the allen surgical table, the table¿s chest support base broke causing the patient to fall.It was reported that the patient was injured, however, specific details of the injury and any required intervention was not provided.During a follow-up call with the customer, the customer stated that there was no immediate injury to the patient, and no immediate intervention was required at the time of the event.The customer also reported that they are awaiting a final evaluation of injury report from the surgeon who performed the patient's surgical procedure at the time of the event.Multiple attempts to obtain additional details of the patient's evaluation have been unsuccessful.The allen chest support is designed to position and support the patient¿s chest in a variety of surgical procedures including, but not limited to spine surgery in prone position.The device is used in conjunction with additional support/positioning devices (surgical table, arm supports, head support) and supports only a portion of the patient in prone position during surgical procedures.Prior to use it is standard practice to inspect and confirm the equipment is in working order, verifying all parts fit together properly, can withstand the weight of the patient, and test prior to use to ensure positioning can be conducted in a safe manner the device ifu instructs ¿do not use if product shows visible damage, prior to using this device, inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.To prevent patient and/or user injury and/or equipment damage, examine the device and surgical-table side rails for potential damage or wear prior to use.Do not use the device if damage is visible, if parts are missing or if it does not function as expected.¿ to date, the customer has not provided any additional details related to this event.Based on the initial details received from the customer (no immediate injury), and that no additional details have been received, there is no indication that an injury (serious or otherwise) occurred with this event.Although there was no serious injury reported, if the reported malfunction were to recur, it could result in serious injury or death.Therefore, this is a reportable malfunction.

• Brand Name: ALLEN ADVANCE CHEST SUPPORT W/PAD
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• 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: 16627052
• Report Number: 3010216206-2023-00001
• Device Sequence Number: 19962620
• Product Code: GDC
• UDI-Device Identifier: 00615521003159
• UDI-Public: 615521003159
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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-71301
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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