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

Model Number 720001B2

Device Problem Positioning Problem (3009)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2nd january 2024 getinge became aware of an issue with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, the intermittent issue of the table simultaneously not responding to the handcontrol and the pedestal control occurred during total knee replacement surgery on the anesthetized patient resulting in a delay of approximately 10 minutes.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the inability to position the table using handcontrol and override panel and delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: MEERA EU WITH 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: 18474219
• MDR Text Key: 332424558
• Report Number: 8010652-2024-00004
• 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
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1