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

Model Number 710001B0

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).H3 other text: device not returned to manufacturer.

Event Description

On 2nd october 2023 getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the base of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.Additional details of the event and user's outcome were requested, however, no information has been received to date.It was confirmed that the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the base of the table, was to reoccur.

• Brand Name: MEERA ST EU WITHOUT AUTO DRIVE
• 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: 17903383
• MDR Text Key: 325234011
• Report Number: 8010652-2023-00098
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710001B0
• Device Catalogue Number: 710001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other