MAUDE Adverse Event Report: MAQUET GMBH UNIVERSAL FRAME, EU; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100724A1

Device Problem Positioning Failure (1158)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

On 19th march 2024, getinge became aware of an issue with one of our devices - 100724a1 - universal frame, eu.As it was stated, the reinforcement bracket screw was blocked during positioning of the patient in preparation for neurosurgery on the anesthetized patient.The issue led to a delay in starting the operation due to changing of the operation plan.Based on the information provided by the getinge technician following service visit on site, the reinforcement system locking/unlocking knob was found to be completely unscrewed.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.

Manufacturer Narrative

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

• Brand Name: UNIVERSAL FRAME, EU
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• 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: 19085812
• MDR Text Key: 339876843
• Report Number: 8010652-2024-00052
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/11/2024

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 Model Number: 100724A1
• Device Catalogue Number: 100724A1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1