MAUDE Adverse Event Report: MAQUET GMBH HYBRID OR TABLE COLUMN, SURFACE-MOUNTED; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001B1

Device Problem Positioning Problem (3009)

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

Event Date 04/20/2023

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 20th april 2023 getinge became aware of an issue with one of our columns ¿ 118001b1 - hybrid or table column, surface-mounted.As it was stated, error was displayed and movements of the table were stopped during the procedure on the anesthetized patient.According to the provided information, it was not possible to manually override the table movements.The issue resulted in a delay and prolonged anesthesia time.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 columns ¿ 118001b1 - hybrid or table column, surface-mounted.As it was stated, error 6/110 was displayed and movements of the table were stopped during the procedure on the anesthetized patient.According to the provided information, it was not possible to manually override the table movements.The issue resulted in a delay causing a prolonged anesthesia time for the 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.The error 6/110 implies that there is an issue in segment 6, namely the column and ¿110¿ means ¿sensor value out of range¿.The affected getinge device has been evaluated by the company¿s service technician.The evaluation revealed the malfunction of the height potentiometer with cable (part number 31147214).After the part was replaced and the column was tested without any faults, the getinge device was released for usage.The affected getinge device was manufactured on 02/16/2012.According to the information from the ssu the height potentiometer was replaced before, around 5 years before the investigated issue occurrence.The last maintenance was held in march 2023, the height potentiometer was checked and no malfunctions were reported.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 height potentiometer was found, it was considered that the getinge device was not up to the specification.In summary and as a result of the performed root cause evaluation, it was concluded that based on available information it can be suspected that the most probable root cause of the reported issue, namely the intermittent error on column causing the table to get stuck during the surgery, which led to the delay in surgery resulting in prolonged anesthesia time, is expected wear and tear related to the device¿s age.There were 3 additional similar complaints found related to this issue investigated herein, therefore the failure ratio is (b)(4)%.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 h4 device manufacture date field deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 03/01/2012.Corrected h4 device manufacture date: 02/16/2012.

Event Description

On 20th april 2023 getinge became aware of an issue with one of our columns ¿ 118001b1 - hybrid or table column, surface-mounted.As it was stated, error 6/110 was displayed and movements of the table were stopped during the procedure (angioplasty) on the anesthetized patient.According to the provided information, it was not possible to manually override the table movements.The issue resulted in a 10-15 minutes delay of surgery and prolonged anesthesia time.The procedure was performed as planned.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.

• Brand Name: HYBRID OR TABLE COLUMN, SURFACE-MOUNTED
• 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: 16851598
• MDR Text Key: 314352001
• Report Number: 8010652-2023-00039
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001B1
• Device Catalogue Number: 118001B1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1