MAUDE Adverse Event Report: DEL MEDICAL EV650; RADIOLOGICAL TABLE

Model Number	EV650
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a service call, the manufacture's technical support representative was providing instructions to the third party service engineer to support diagnosing a performance issue.While the manufacturers technical support representative believed he was clearly communicating that he was previewing the instructions,the third -party engineer began to perform the operations before receiving the complete safety precautions instructions.The manufacturer's representative was verbally walking the third-party engineer through section 5.4 of the ev650 service manual.This section contains a warning immediately preceding the step where the incident occurred that reads "proceed with caution.The following steps carry risk of injury or equipment damage.When you make the following connection the table will begin to move immediately.The table will stop only when you disconnect the override cable.The limi switches will stop the table.To avoid damages stop the table as soon as it is back within limits range".

• Brand Name: EV650
• Common Device Name: RADIOLOGICAL TABLE
• Manufacturer (Section D): DEL MEDICAL; 241 covington drive; bloomingdale IL 60108
• MDR Report Key: 11897721
• Report Number: 1418964-2021-00001
• Device Sequence Number: 11648424
• Product Code: IZZ
• UDI-Device Identifier: 00858340006011
• UDI-Public: 00858340006011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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
• Operator of Device: No Information
• Device Model Number: EV650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention