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

Model Number 720001B0

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

At the time of this report, the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported to us.During a surgery a part of the tables base was lifted off the floor.A nurse stuck her foot in the gap between floor and or table.Next the tables' base fell down on the floor.The nurse was injured and received a fracture on one of the toes.Manufacturer reference # (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected table and has not found any damage or malfunction.We assume that the following has happened.The tables' downward movement was blocked by an obstacle, e.G.An instrument table.When the table or a part of it was moved downwards, the tables base was lifted of the floor.Once the obstacle broke or slipped out, the tables base was lowered back on the floor and crushed the doctors foot.In the instructions for use (ifu) it is stated the user has to pay attention and avoid collisions when operating the table.In chapter 2 of the ifu possible hazards are stated: "warning! risk of injury! when adjusting and moving the or table, the table top or the accessories, collisions may occur with the patient, between the individual products or parts pointing downwards.During the adjustment procedures, always pay attention to the or table and accessories and avoid collisions.Ensure that tubes, cables and drapes are not trapped." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

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
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 12630110
• MDR Text Key: 276334392
• Report Number: 8010652-2021-00029
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female