MAUDE Adverse Event Report: MAQUET GMBH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 141901JC

Device Problems Positioning Failure (1158); Solder Joint Fracture (2324)

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

Event Date 01/28/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : 3rd party evaluation.

Event Description

On 18th march 2024, getinge became aware of an issue with one of our devices.On 3rd april 2024, additional information was received and it was confirmed that the incident with the patient occurred on 141901jc extension device.Later on, further details were provided.As it was stated, the 31138834 tension block short welding group was broken and locking/unlocking was not possible.Consequently, the traction device had to be replaced.As a result, the procedure was delayed.The issue occurred during femur fracture surgery on the anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: EXTENSION DEVICE
• 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: 19151989
• MDR Text Key: 341515506
• Report Number: 8010652-2024-00056
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: JO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 141901JC
• Device Catalogue Number: 141901JC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1