MAUDE Adverse Event Report: MAQUET GMBH ALPHAMAXX MOBILE OPERATING TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	113322B4
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our mobile tables ¿ 113322b4 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during preparation for the surgery, the anesthetized patient was placed on the table in the right lateral position and the staff initated movement of the table via 113390a0 - handcontrol with cable.The table top was raised and after that the staff tried to put the patient into lumbar bridge position by pressing a button on the remote control.This action triggered an alarm, the movement was stopped and could not be continued into selected position.The staff used override panel to initate the desired movement which resulted in collision and broken lower backplate.Consequently, changing of operating table was required due to the incident.The surgery was completed on another table with a delay of nearly 30 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with our mobile tables ¿ 113322b4 - alphamaxx (460 mm longit.Shift), eu.During the preparation for the surgery, the anesthetized patient was placed on the table in the right lateral position and the staff initiated movement of the table via 113390a0 - handcontrol with cable.The table top was raised and after that, the staff tried to put the patient into a lumbar bridge position by pressing a button on the remote control.This action triggered an alarm, the movement was stopped and could not be continued into the selected position.The staff used the override panel to initiate the desired movement which resulted in a collision with the unspecified items placed bellow the operating table and caused a broken lower back plate.Consequently, change of the operating table was required due to the incident.The surgery was completed on another table with a delay of nearly 30 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device has been evaluated by the hospital staff in coordination with the service technician.Due to the alarm on the remote control, the user used the override panel, which is designed for emergency situations.During the use of the override panel, the user did not pay attention of the things placed under the table top.In the user manual, the user is also informed that there is a risk of the property damage caused as a result of collision when moving/adjusting the mobile operating table.The user is informed to remove potential hindrances before moving / adjusting the mobile operating table and to avoid collisions (ifu 1133.22 en 16, page 26).The user is also informed that when operating the or table using the override control panel, the collision warning function is not active (ifu 1133.22 en 16, page 39).The reported issue was caused by a user error related to not following warnings given in the instruction for use.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 back plate was broken due to user error, it was considered that the getinge device was up to specification as the user was alarmed about possible collision.There were no similar complaints found related to the failure pattern described in this event, therefore it appears to be isolated to this single occurrence when considering this particular device range.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.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, d3 manufacturer, d4 catalog #, d4 unique identifier (udi) # fields deems required.This is based on the internal evaluation.Previous d1 brand name: alphamaxx (460 mm longit.Shift), eu corrected d1 brand name: alphamaxx mobile operating table previous d3 manufacturer: maquet sas corrected d3 manufacturer: maquet gmbh previous d4 catalog #: 113322b4 corrected d4 catalog #: n/a previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(6).The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: ALPHAMAXX MOBILE OPERATING TABLE
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; avenue de la pomme de pin; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 16476452
• Report Number: 8010652-2023-00014
• Device Sequence Number: 12594113
• Product Code: FQO
• UDI-Device Identifier: 04046768040007
• UDI-Public: (01)04046768040007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 113322B4
• Device Catalogue Number: 113322B4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 12/06/2024
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/29/2023; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1133.90A0 - HANDCONTROL WITH CABLE.
• Patient Sex: Unknown