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

Model Number 118001B2

Device Problems Device Sensing Problem (2917); Positioning Problem (3009)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

On 2nd june 2023 getinge became aware of an issue with one of our columns ¿ 118001b2 - hybrid or table column, surface-mounted.As it was stated, error messages regarding unknown system position were displayed during surgery.The staff reset the whole system, however, it did not resolve the issue.The error appeared multiple times and every time the fault occurred soft reset of the device was performed in order to complete the scan of the patient.The issue led to approximately a 30 minutes delay of the surgery.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

Additional information will be provided following the conclusion of the investigation.Event site postal code: (b)(6).Event site telephone: (b)(6).H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of our columns ¿ 118001b2 - hybrid or table column, surface-mounted.As it was stated, error messages regarding unknown system positions were displayed during surgery.The staff reset the whole system, however, it did not resolve the issue completely.The error appeared multiple times and every time the fault occurred soft reset of the device was performed in order to complete the scan of the patient.The issue led to approximately a 30 minutes delay of the surgery.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 trend 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 injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio is 0,04% for the issue investigated herein as there was one similar reportable customer product complaint.The affected table column has been evaluated by the service technician.The evaluation revealed that the reported issue, namely the error messages regarding the unknown system position that led to the delay in surgery resulting in prolonged anesthesia time, was to reoccur, was caused by the issues with a potentiometer.The technician identified the affected part as a trend potentiometer (part number 31154789).The affected potentiometer was replaced by the technician which resolved the problem.The technician emphasized that the issue was related to expected wear and tear.The affected getinge device was manufactured on 05/23/2017.The review of the customer product complaints database revealed that in the past there were no customer product complaints related to the malfunction of this particular potentiometer.In summary and as a result of the performed root cause evaluation, it was concluded that no malfunctions with the potentiometer were previously reported so it can be suspected that the most probable root cause of the reported issue, namely the error messages regarding unknown system position that led to the delay in surgery resulting in prolonged anesthesia time, is expected wear and tear.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 fields deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 07/01/2017.Corrected h4 device manufacture date: 05/23/2017.

Event Description

Manufacturer reference number (b)(4).

• 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: 17115973
• MDR Text Key: 317460785
• Report Number: 8010652-2023-00045
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001B2
• Device Catalogue Number: 118001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1