MAUDE Adverse Event Report: MAQUET GMBH OR TABLE COLUMN, MANOEUVRABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116001D0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

Getinge became aware of an issue with one of our columns - 116001d0 or table column, manoeuvrable.The following was reported to us.The table top 116030a0 was mounted on the column 116001d0.During a surgery, the table¿s base was slightly lifted off the floor.This was not noticed by the or team, because the view was blocked by sterile drapes.At the end of the surgery, the patient was moved.When this was done the tables base crushed down at the foot of a member of the surgical team.The staff member was injured and received a fracture on the foot.One of the toes was broken.We decided to report the issue due to serious injury of the staff.According to the information obtained from the service unit, no damage or malfunction of the 116001d0 column was found.It was established that when the event occurred, 116001d0 or table column, manoeuvrable did meet its specification as no technical malfunction was found and the event was considered to be related to user error.The device was being used for a patient¿s treatment upon the event occurrence.When the event occurred, the column was directly involved in the reported incident.The review of received customer product complaints revealed that this complaint was the first one claimed for the investigated issue.Comparing the number of complained devices (1) to the number of units placed on the market up to the end of (b)(6) 2021 (3799) we can conclude the failure ratio is 0,026 % for the investigated issue.The affected table was investigated by a getinge-maquet field service engineer.No damage or malfunction could be found on the table.Therefore, we assume that a use error has caused this issue.We assume that the following has happened.An obstacle (most likely a stretcher) was under the table top.Next, the table top or a part of it was lowered onto it.Since the table downward movement was blocked, the table¿s base was partly lifted of the ground.The or team has not recognized this, because the view was blocked by surgical drapes.A foot was put under the table¿s base.When the patient was moved, the center of gravity changed or the obstacle slipped out.This caused the table¿s base to fall back on the ground and injure the 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 transporter, the table top or the accessories, as well as when carrying out a table top transfer, collisions may occur between the patient and individual products or parts that are pointing downwards.During adjustments, observe the or table, the transporter, the table top and accessories constantly and avoid collisions.Ensure that tubes, cables and drapes are not trapped.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2021) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of our columns - 116001d0 or table column, manoeuvrable.The following was reported to us.The table top 116030a0 was mounted on the column 116001d0.During a surgery, the table¿s base was slightly lifted off the floor.This was not noticed by the or team, because the view was blocked by sterile drapes.At the end of the surgery, the patient was moved.When this was done the tables base crushed down at the foot of a member of the surgical team.The staff member was injured and received a fracture on the foot.One of the toes was broken.We decided to report the issue due to serious injury of the staff.

• Brand Name: OR TABLE COLUMN, MANOEUVRABLE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 15232331
• MDR Text Key: 297953227
• Report Number: 8010652-2022-00020
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 116001D0
• Device Catalogue Number: 116001D0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other