MAUDE Adverse Event Report: MEERA EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number MEERA EU WITH AUTO DRIVE

Device Problems Device Handling Problem (3265); Unintended Electrical Shock (4018)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this incident was a user error.Against the instructions for use (ifu) the table was modified and a damaged cord was used.According to the ifu modification on the product, like using another power cord, is not allowed.The user is warned as follows concerning the risks related to such modifications: "potentially fatal! risk caused by unauthorised modifications.Modifications at the product are not permitted." in the ifu the user is told, not to use or repair by himself a defective product.The charging procedure for the table is described in the ifu.It is described how the table should be connected to mains supply.According to this description, first the supplied power cord should be connected to the mains connection of the or table.Afterwards the cable should be plugged into the mains power outlet.According to the information we received from our customer this order was not followed and the cable was first connected to the mains power outlet.A service technician from getinge-maquet has investigated the affected table and the used power cord.The table was neither damaged nor malfunctioning.The used power cord was not the originally delivered cord and showed an exposed wire.Ghe contacts full phone# is: (b)(6).Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The following was reported.A member of staff wanted to charge the table.The used power cord was not the originally delivered card and was damaged.The power cord was connected to mains.Afterwards he wanted to connect the cable to the or table.Due to the damage at the cable, the user received an electric shock.He suffered burns at his left index finger.The burn was treated and the patient stayed at the intensive care unit for 24 hours for observation.He could leave it after that without any further events.Manufacturer reference # (b)(4).

• Brand Name: MEERA EU WITH AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• MDR Report Key: 10205690
• MDR Text Key: 196774496
• Report Number: 3013876692-2020-00034
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEERA EU WITH AUTO DRIVE
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2020
• Distributor Facility Aware Date: 06/25/2020
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR