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

Model Number 118010A0

Device Problems Positioning Failure (1158); Insufficient Information (3190)

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

Event Date 04/29/2022

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up will be submitted.(b)(6).

Event Description

On (b)(6) 2022 getinge became aware of an issue with 118010a0 - basis table top, individual configuration.As it was stated, during the prostate surgery, error 12/105 occurred and table top could not be adjusted.A transfer of the anesthetized patient to another table top was required.The surgery was delayed by 30 minutes due to the issue.The patient was not harmed.

Manufacturer Narrative

Getinge became aware of an issue with 118010a0 - basis table top, individual configuration.As it was stated, during the prostate surgery, error 12/105 occurred and table top could not be adjusted.A transfer of the anesthetized patient to another table top was required.The surgery was delayed by 30 minutes due to the issue.The patient was not harmed however, we decided to report the issue based on potential as delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device have been evaluated by the company¿s service technician.The technician confirmed the malfunction of the table top.It has been evaluated that the potentiometer was defective.Additionally, the pulse generator was renewed.The involved potentiometer was returned for further evaluation.The root cause analysis has been performed by the process assurance team at the manufacturing site.The visual inspection revealed damage to the shrink tubing on the green cable.The shaft of the potentiometer was initially rigid.When turning the shaft of the potentiometer, minor resistance could have been felt.Additional test was performed by the potentiometer¿s supplier.The result showed a bent slider, which has caused potentiometer to hook when it has run against the direction of rotation.The damage to the shrink tube was due to too much heat during grinding process.Supplier¿s staff was re-sensitized to the defect pattern.To conclude, it has been established that the issue was brought on by a failure during assembly work at the supplier site.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As the malfunction of the potentiometer was found, it was considered that the getinge device was not up to the specification.In summary, this complaint is the sixth one registered for magnus table tops where the patient¿s anesthesia time was prolonged, because the table top could not be adjusted due to an electronic malfunction and the third one in which the issue was caused by the potentiometer malfunction.Comparing the number of complained devices (3) to the number of magnus table tops with aforementioned catalog numbers placed on the market (6389) we can conclude the failure ratio is (b)(4) for the electronic issue resulting in prolonged anesthesia time considering potentiometer malfunction as a root cause of the situation occurrence.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, d3 manufacturer, h4 device manufacture date, h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 29th april 2022 getinge became aware of an issue with 118010a0 - basis table top, individual configuration.As it was stated, during the prostate surgery, error 12/105 occurred and table top could not be adjusted.A transfer of the anesthetized patient to another table top was required.The surgery was delayed by 30 minutes due to the issue.The patient was not harmed.Corrected b5 describe event or problem: on 29th april 2022 getinge became aware of an issue with 118010a0 - basis table top, individual configuration.As it was stated, during the prostate surgery, error 12/105 occurred and table top could not be adjusted.A transfer of the anesthetized patient to another table top was required.The surgery was delayed by 30 minutes due to the issue.The patient was not harmed however, we decided to report the issue based on potential as delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.Previous d3 manufacturer: holger ullrich.Corrected d3 manufacturer: maquet gmbh.Previous h4 device manufacture date: 01/12/2022.Corrected h4 device manufacture date: 12/23/2021.Previous h6 medical device ¿ problem code: insufficient information|||3190.Corrected h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem|positioning failure|1158.

Event Description

On 29th april 2022 getinge became aware of an issue with 118010a0 - basis table top, individual configuration.As it was stated, during the prostate surgery, error 12/105 occurred and table top could not be adjusted.A transfer of the anesthetized patient to another table top was required.The surgery was delayed by 30 minutes due to the issue.The patient was not harmed however, we decided to report the issue based on potential as delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

• Brand Name: BASIS TABLE TOP, INDIVIDUAL CONFIGURATION
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 14314439
• MDR Text Key: 299778224
• Report Number: 8010652-2022-00004
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118010A0
• Device Catalogue Number: 118010A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1