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

Model Number 6988

Device Problems Misconnection (1399); Smoking (1585); Electrical Shorting (2926); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 322198049
• Report Number: 2921578-2023-00013
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430107023
• UDI-Public: 00842430107023
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6988
• Device Catalogue Number: 6988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1