MAUDE Adverse Event Report: MAQUET GMBH 1150 OR-TABLE COLUMN, MOBIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 115002C0

Device Problems Circuit Failure (1089); Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).Initial reporter: getinge service technician.H3 other text : device not returned to manufacturer.

Event Description

On (n)(6) 2024 getinge became aware of an issue with one of our columns - 115002c0 - 1150 or-table column, mobil.As it was stated, upon the preventive maintenance activities being performed on the device, the power cables of the batteries needed to be replaced urgently as they were discolored and showing signs of getting warm.Severe overheating of insulation was confirmed with the photographic evidence.As it was assessed, the issue could result in short circuit with the subsequent complete system failure.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely severe overheating of power cables of the batteries and insulation which could potentially lead to complete system failure, was to occur during the procedure.

• Brand Name: 1150 OR-TABLE COLUMN, MOBIL
• 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: 18766181
• MDR Text Key: 336099517
• Report Number: 8010652-2024-00023
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 115002C0
• Device Catalogue Number: 115002C0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1