MAUDE Adverse Event Report: MAQUET GMBH BASIS TABLE TOP,INDIVIDUAL CONFIGURATION; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118010A0

Device Problem Positioning Problem (3009)

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.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our table tops ¿ 118010a0 - basis table top,individual configuration.As it was stated, it was not possible to actuate the movements in the table top during the laparoscopic procedure with the anesthetized patient on the table.The staff tried to find the cause of the malfunction which resulted in a delay of around 20 minutes.Eventually, the surgery was finished on the affected table top.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with 118010a0 - basis table top, individual configuration.During the laparoscopic procedure with the anesthetized patient on the table, it was not possible to actuate the movements of the table top.The operating theater staff tried to find the cause of the malfunction, which resulted in a delay of around 20 minutes.Eventually, the surgery was finished on the affected table top.There was no injury of the patient reported, however, we decided to report the issue to competent authorities as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device has been evaluated by the hospital staff in coordination with the getinge service technician and technical support at the manufacturing site.The technician suspected that the malfunction of the table top was caused by the defective pcb or defective dc motors.After replacing the pcb the problem still occurred.The technician established that the malfunction of the table top was most likely caused by the defective dc motors which could not be replaced in the field due to the nature of failure and design of the table top.In order to repair such failure the affected table top should be sent to repair center, however the customer decided that the repair will not be performed and the table top will be scrapped.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As the malfunction of the dc motors was found, it was considered that the getinge device was not up to specification.The dc motors malfunction was most likely related to the wearing of the part due to prolonged usage.There were no similar complaints found related to this issue failure pattern as described in this event , therefore it appears to be isolated to this single occurrence when considering this particular device range.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of h6 component codes field deems required.This is based on the internal evaluation.Previous h6 component codes: mechanical|motor(s)||486.Electrical and magnetic|circuit board||427.Corrected h6 component codes: mechanical|motor(s)||486.

• Brand Name: BASIS TABLE TOP,INDIVIDUAL CONFIGURATION
• 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: 15821409
• MDR Text Key: 307075331
• Report Number: 8010652-2022-00040
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118010A0
• Device Catalogue Number: 118010A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1