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

Model Number 720001B0

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 1st september, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table tilted independently causing the patients head and sholders to slide off.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of reoccurance.

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table tilted independently causing the patient¿s head and shoulders to slide off.There was no injury reported, however, we decided to report the issue in abundance of caution as serious injury cannot be excluded in case of recurrence of undesirable movement resulting in patient slipping from the table.The getinge technician examined the operating table.The alleged situation could not be duplicated.The device was returned to the usage.The result of the investigation allow us to conclude that no issues could have been found on the machine, thus the root cause of the situation occurrence remains impossible to define.In the ifu (ifu 7200.01 en 11) the user is warned about possible dangers and informed how to use the operating table in a safely manner and which precautions shall be taken to avoid any safety relevant risk occurrence.With the investigation performed it was concluded that upon the event occurrence, the device was being used for patient¿s treatment, thus was also directly involved with the reported incident.As no actual malfunctions were found it was considered that getinge device was up to the specification.A review of received customer product complaints related to investigated issues, revealed that the complaint investigated herein is the fourth complaint registered for meera operating tables where the independent tilt of the table caused the patient to slide off from the table.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio is 0,066%.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes we will continue to monitor the customer experiences with the device for any future information.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 1st september, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table tilted independently causing the patients head and sholders to slide off.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of reoccurance.Corrected b5 describe event or problem: on september 1st, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table tilted independently causing the patient¿s head and shoulders to slide off.There was no injury reported, however, we decided to report the issue in abundance of caution as serious injury cannot be excluded in case of recurrence of undesirable movement resulting in patient slipping from the table.

Event Description

On september 1st, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table tilted independently causing the patient¿s head and shoulders to slide off.There was no injury reported, however, we decided to report the issue in abundance of caution as serious injury cannot be excluded in case of recurrence of undesirable movement resulting in patient slipping from the table.

• Brand Name: MEERA EU WITHOUT AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 15416400
• MDR Text Key: 299869350
• Report Number: 8010652-2022-00028
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1