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

Model Number 116001A0

Device Problems Circuit Failure (1089); Positioning Failure (1158)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our columns ¿ 116001a0 - otesus or table column, stationary.As it was stated, the table could not be positioned as required for the extubation of the patient.The operating table top should be placed in the upper body elevation, however, it remained tilted in the left lateral position.The patient had to be extubated in this position and transferred to bed as quickly as possible.According to the provided information, during subsequent attempts to level the table, the table only tilted to the left using a wide variety of keys and damaged the column.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely inability to position patient as required, was to reoccur.

• Brand Name: OTESUS OR TABLE COLUMN, STATIONARY
• 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: 17952807
• MDR Text Key: 326086214
• Report Number: 8010652-2023-00110
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 116001A0
• Device Catalogue Number: 116001A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1