MAUDE Adverse Event Report: MAQUET GMBH CARBON FIBRE TABLE TOP, NEURO; TABLE, RADIOLOGIC

Model Number 118016A7

Device Problem Device Sensing Problem (2917)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6) medical center.

Event Description

On 14th march 2024, getinge became aware of an issue with one of our table tops - 118016a7 - carbon fibre table top, neuro.As it was stated, the error code 174-9 (table top position error) occurred and the linked angiographic system stopped.The issue occurred at the end of the procedure at the time of taking x-rays.The error prevented operation of the angiographic system and the patient had to be moved to another operating room.Following the transfer, the procedure was continued.The issue resulted in a delay.According to provided information, the patient was probably anesthetized during the incident.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: CARBON FIBRE TABLE TOP, NEURO
• 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: 18995034
• MDR Text Key: 339010734
• Report Number: 8010652-2024-00045
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024

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 Operator: Health Professional
• Device Model Number: 118016A7
• Device Catalogue Number: 118016A7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ANGIOGRAPHY DEVICE