MAUDE Adverse Event Report: MIZUHO OSI TABLE, PROAXIS; OPERATING TABLE

Model Number	6988
Medical Device Problem Codes	Misconnection (1399); Smoking (1585); Electrical Shorting (2926); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An electrical wire cord burn with charring and smoke was reported on proaxis table.The cord was changed when the patient was already on the table.Once they turned the power on and started the case again anesthesia smelled an electrical burning smell and noticed charring and smoke at the cord going into the table.There was also charring around where the cord enters the table as well as charring of some iv tubbing as observed by or staff.No patient injury was reported.
Additional Manufacturer Narrative
Based on the information obtained from investigation, the table did not have any functional issues.It was found that the power inlet assembly was burned from outside due to a liquid going into the power inlet.The hospital took a decision to decommission the table until futher notice.
Additional Manufacturer Narrative
Based on the information obtained from investigation, the table did not have any functional issues.It was found that the power inlet assembly was burned from outside due to a liquid going into the power inlet.The fluid that got into the ac power inlet module shorted out the power cable when it was powered on.The manual instructs users to wipe the table clean only and to avoid exposing it to excessive moisture.
Event or Problem Description
An electrical wire cord burn with charring and smoke was reported on proaxis table.The cord was changed after lim alarm when the patient was already on the table.Once they turned the power on and started the case again anesthesia smelled an electrical burning smell and noticed charring and smoke at the cord going into the table.There was also charring around where the cord enters the table as well as charring of some iv tubbing as observed by or staff.No patient injury was reported.

• Brand Name: TABLE, PROAXIS
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17643624
• Report Number: 2921578-2023-00013
• Device Sequence Number: 5590602
• Product Code: JEA
• UDI-Device Identifier: 00842430107023
• UDI-Public: 00842430107023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: 6988
• Device Catalogue Number: 6988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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