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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.¿ the device has not been returned for inspection therefore, a root cause into the reported malfunction can not be determined at this time.If the devices are received, inspection findings will be submitted in a supplemental report.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.
Event or Problem Description
The customer reported that during a surgical procedure using the allen surgical table, the table¿s chest support base broke.There was no patient injury reported.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
The device was returned for product investigation.Upon visual inspection, the device had no physical damage.Complaint investigation indicated, that there was no evidence of a malfunction or product issue and the alleged condition was not duplicated.Based on this information, no further action is required.
Event or Problem Description
The customer reported, that during a surgical procedure.Using the allen surgical table, the table¿s chest support base broke.There was no patient injury reported.This report was filed in our complaint handling system as (b)(6).

• 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: 17491382
• Report Number: 3010216206-2023-00004
• Device Sequence Number: 15297859
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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