MAUDE Adverse Event Report: MAQUET GMBH MAGNUS CARBON-FIBRE TABLE TOP,185 CM, EU; TABLE, RADIOLOGIC

Model Number 118016A1

Device Problem Positioning Failure (1158)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

On 7th october 2023 getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 hybrid or table column, surface-mounted.According to initially provided information, during longitudinal shift the table top moved to a certain position and one side of the table top dropped by 2-3 cm resulting in lost position of the table and inability to move the device.As it was stated, the issue occurred during preoperative preparation and patient was on the operating table, however, was not under anesthesia.After suspending the operation for approximately 15 minutes, the equipment was restarted and the procedure continued.On (b)(6) 2023, additional information was received.According to information provided in customer investigation, the incident occurred during upper extremity arterial thrombectomy.The rest of the day's operations had to be postponed.We decided to report the issue, namely the interruption of surgery leading to a procedural delay, which depending on patient conditions could lead to serious injury in case of event reoccurrence.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: e1c event site address: e1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

• Brand Name: MAGNUS CARBON-FIBRE TABLE TOP,185 CM, EU
• Type of Device: TABLE, RADIOLOGIC
• 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: 18281887
• MDR Text Key: 329933321
• Report Number: 8010652-2023-00133
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118016A1
• Device Catalogue Number: 118016A1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 118001B2 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED.