MAUDE Adverse Event Report: MAQUET GMBH ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113312B3

Device Problem Unintended System Motion (1430)

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.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our mobile tables ¿ 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, the back side of the table went all the way down during a surgery while the anesthetized patient was on the table.According to the provided information, the staff put chair under the back side of the table and were able to complete the surgery.Additional information received suggests that the leg side of the table was also going down.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during surgery, was to reoccur.

Event Description

On 4th october 2023 getinge became aware of an issue with one of our mobile tables ¿ 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, the back side of the table went all the way down during a surgery while the anesthetized patient was on the table.According to the provided information, the staff used 'back up' function, put chair under the back side of the table and were able to complete the surgery.Additional information received suggests that the leg side of the table was also going down.The issue led to a short delay in medical procedure.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during surgery leading to delay and prolonged anesthesia time, was to reoccur.

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.The correction of b5 describe event or problem and h6 health effect ¿ impact codes fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 4th october 2023 getinge became aware of an issue with one of our mobile tables ¿ 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, the back side of the table went all the way down during a surgery while the anesthetized patient was on the table.According to the provided information, the staff put chair under the back side of the table and were able to complete the surgery.Additional information received suggests that the leg side of the table was also going down.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during surgery, was to reoccur.Corrected b5 describe event or problem: on 4th october 2023 getinge became aware of an issue with one of our mobile tables ¿ 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, the back side of the table went all the way down during a surgery while the anesthetized patient was on the table.According to the provided information, the staff used 'back up' function, put chair under the back side of the table and were able to complete the surgery.Additional information received suggests that the leg side of the table was also going down.The issue led to a short delay in medical procedure.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during surgery leading to delay and prolonged anesthesia time, was to reoccur.Previous h6 health effect ¿ impact codes: no health consequences or impact|||2199.Corrected h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 113312b3 - alphamaxx motor drive unit, eu-spec side rail.As it was stated, the back side of the table went all the way down during surgery while the anesthetized patient was on the table.According to the provided information, the staff used the 'back up' function, put a chair under the back side of the table and were able to complete the surgery.Additional information received suggests that the leg side of the table was also going down.The issue led to a short delay in a medical procedure.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during surgery leading to delay 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 5/3 valve and double-check valve were replaced, 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 issue investigated herein is a single and isolated case.The affected mobile table has been evaluated by the service technician at the customer site.The technician tested the table but no malfunction was found, however, the technician suspected that there was air in the hydraulic system which allows the operating tables movements and controls adjusting mechanisms.Therefore, the 5/3 valve and double-check valve were replaced.The affected getinge device was manufactured on 05/15/2007.The review of the customer product complaints database revealed that in the past there were no customer product complaints related to the malfunction of the 5/3 valve and double-check valve.In summary and as a result of the performed root cause evaluation, it was concluded that no malfunctions with the 5/3 valve and double-check valve were previously reported.It was clarified with the technician that no malfunctions with the device were detected during the last maintenance.Based on all information, it can be suspected that the most probable root cause of the reported issue, namely the unintended movement of the table during surgery leading to delay resulting in prolonged anesthesia time, is related to the age of the device as the device was in used for 16 years and there is no evidence that 5/3 valve and double-check valve were previously replaced.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: 05/01/2007.Corrected h4 device manufacture date: 05/15/2007.

• Brand Name: ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL
• 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: 17947733
• MDR Text Key: 325807022
• Report Number: 8010652-2023-00109
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 113312B3
• Device Catalogue Number: 113312B3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• 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