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

Model Number 720001B2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

No malfunction of the product was reported by the customer.The incident was caused by a user error.The customer made a functional check of the table after the procedure and no malfunction was detected.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

The following appears to have happened and was reported to us.The table top of the used or table can be lowered.In this case the downward movement of the or table top was blocked by an instrument trolley and the or tables base was lifted from the ground which was not recognized by the user.It was described that the or table was ¿rocking¿.The medical staff stabilized the patients position on the table top.At some point a surgeon put her foot under the lifted table base.When the table top was raised, the table base was lowered on the doctors foot.The surgeon injured her food and attended the accident and emergency department.She had two broken bones in her foot.

Event Description

In the meantime we were informed by the customer that in addition to the injured foot of the doctor, the actual surgery of the patient was delayed for approximately 1 hour due to the incident.Manufacturer reference # (b)(4).

• Brand Name: MEERA EU WITH 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: 10874299
• MDR Text Key: 217288639
• Report Number: 8010652-2020-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other