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

Model Number 720001B2

Device Problem Overheating of Device (1437)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).E1h event site postal code: (b)(6).E1i event site telephone:(b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 22nd january 2024 getinge became aware of an issue with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, charger got overheated at the end of operation.We decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the charger, 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: 18612910
• MDR Text Key: 334543270
• Report Number: 8010652-2024-00015
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1