MAUDE Adverse Event Report: MAQUET GMBH TABLE TOP FOR OPERATIONS ON THE HEAD; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 115025DE

Device Problems Positioning Failure (1158); Positioning Problem (3009)

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

Event Date 09/13/2023

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 13th september 2023 getinge became aware of an issue with one of our table tops ¿ 115025de - table top for operations on the head.As it was stated, during an ent surgery, there was a problem with translation movement as the table top could not return to zero position.The problem resulted in a delay in treatment (less than 10 minutes) of the anestethized patient.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.

Event Description

On 13th september 2023, getinge became aware of an issue with one of our table tops ¿ 115025de - table top for operations on the head.As it was stated, during an ent surgery, there was a problem with longitudinal movement as the table top could not return to zero position.The problem resulted in a delay in treatment (less than 10 minutes) of 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 the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our table tops ¿ 115025de - table top for operations on the head.As it was stated, during an ent surgery, there was a problem with longitudinal movement as the table top could not return to zero position.The problem resulted in a delay in treatment (less than 10 minutes) of 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 the delay in surgery resulting in prolonged anesthesia time, was to reoccur.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 longitudinal displacement potentiometer was found, it was considered that the getinge device was not up to the specification.A review of the received customer product complaints revealed that there were no serious injuries to a user nor to a patient or operator when this particular issue occurred.The complaint investigated herein is a single and isolated case.The affected getinge device has been evaluated by the company¿s service technician.The technician has confirmed a malfunction of the table top.The table top was readjusted as the longitudinal movement was blocked at the maximum longitudinal displacement position in the foot direction.The table top was tested and released for usage.The affected getinge device was manufactured on 03/14/2005.The review of the customer product complaints database revealed that in the past there were no customer product complaints related to the issue with longitudinal displacement potentiometer reported for the investigated device.In summary and as a result of the performed root cause evaluation, it was concluded that no malfunctions with the longitudinal potentiometer were previously reported so it can be suspected that the most probable root cause of the reported issue, the longitudinal displacement zero position issue, what resulted in a delay in surgery leading to prolonged anesthesia time for the patient, is wear and tear related to the device¿s age.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 b5 describe event or problem, h4 device manufacture date and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 13th september 2023 getinge became aware of an issue with one of our table tops ¿ 115025de - table top for operations on the head.As it was stated, during an ent surgery, there was a problem with translation movement as the table top could not return to zero position.The problem resulted in a delay in treatment (less than 10 minutes) of the anestethized patient.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.Corrected b5 describe event or problem: on 13th september 2023, getinge became aware of an issue with one of our table tops ¿ 115025de - table top for operations on the head.As it was stated, during an ent surgery, there was a problem with longitudinal movement as the table top could not return to zero position.The problem resulted in a delay in treatment (less than 10 minutes) of 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 the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Previous h4 device manufacture date: 03/01/2005.Corrected h4 device manufacture date: 03/14/2005.Previous h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem||3009.Corrected h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem|positioning failure|1158.

• Brand Name: TABLE TOP FOR OPERATIONS ON THE HEAD
• 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: 17816153
• MDR Text Key: 324219023
• Report Number: 8010652-2023-00093
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 115025DE
• Device Catalogue Number: 115025DE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1