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

Model Number	A-71301
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The allen advance chest support with pad has been removed from use and will be returned to allen medical for evaluation and investigation.The investigation is currently ongoing.Allen medical is unable to confirm at this time if the device malfunctioned in a way that would potentially cause or contribute to a serious injury.This report is being filed in an abundance of caution until the investigation is complete.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Hillrom/allen medical received a report from the account stating the chest support bracket broke clean away at site of the rail.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• 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
• MDR Report Key: 9880976
• Report Number: 3010216206-2020-00001
• Device Sequence Number: 11732978
• Product Code: GDC
• UDI-Device Identifier: 00615521003159
• UDI-Public: 615521003159
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: No Information
• Device Model Number: A-71301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1