MAUDE Adverse Event Report: HOLGER ULLRICH MEERA EU WITHOUT AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

The affected or table can be operated by using the following control devices: corded control device, ir remote control, foot switch or override control panel.The override control panel is for emergency operation.If there are any malfunctions or if the control device is defective, then the mobile operating table can be controlled using the override control panel.The collision warning function is not active if the table is operated via the override control panel.The user is advised in the ifu concerning the use of this panel as follows: "[.] when operating the or table using the override control panel, the collision warning function is not active.Watch every adjustment carefully and avoid collisions, especially when implementing extreme inclination and lateral tilt settings." a getinge-maquet representative who was in contact with the customer has stated that the table was operated via the override control panel when this issue occurred.The back plate collided with a part of the column and broke.Therefore we assume a use error as most probable root cause for this issue.A getinge-maquet representative has contacted the customer and offered further training for the staff of the affected hospital.The back plate consists among other parts of a hard paper plate that is covered by a pad.The pad is between the hard paper plate and the patient.The clinic confirmed that this pad was in place.A picture of the damaged hard paper plate was provided for a similar incident.The tear was affecting the edge of the plate.Most likely during patient transfer from the table, the patient received a scratch.Further details concerning this injury were requested, but not provided.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The following was reported.The column control panel was used to operate the operating room table during a surgery.The tables' back plate was lowered, hit the column and broke.Due to this issue the surgery was delayed and the patient received a superficial scratch.No serious injury was reported.We report this as adverse event in abudance of caution.Manufacturer reference# (b)(4).

• Brand Name: MEERA EU WITHOUT AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 9769130
• MDR Text Key: 188643695
• Report Number: 3013876692-2020-00013
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2020
• Distributor Facility Aware Date: 01/31/2020
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other