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

Model Number	113322F5
Medical Device Problem Codes	Positioning Failure (1158); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th february 2024, getinge became aware of an issue with one of our mobile tables - 113322f5 - alphamaxx surgical table w/auto drive.As it was stated, the table was stuck in the uppermost position during procedure and would not move.According to the customer allegation, the position put the patient at risk of falling off table.No additional details regarding the performed procedure and patient positioning have been received to date.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the inability to move the table resulting in delay or interruption in life-saving surgery and potentially creating risk of patient falling from the table, was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables - 113322f5 - alphamaxx surgical table w/auto drive.As it was stated, the table was stuck in the uppermost position during procedure and would not move.According to the customer allegation, the position put the patient at risk of falling off table.No additional details regarding the performed procedure and patient positioning have been received.The incident was initially assessed as reportable based on the potential for serious injury if the situation, namely the inability to move the table resulting in delay or interruption in life-saving surgery and potentially creating risk of patient falling from the table, was to reoccur.Recently, the record has been reevaluated.According to the performed review, the information regarding the initial occurrence of the malfunction on this device was received in december 2023.Based on additional input from getinge employee it was possible to determine that the customer did not accept the quotation and no repair was performed after the issue had been detected.As the customer deliberately used a defective product, it has been concluded that the scenario described in the record is considered as non-reportable.It was established that the device failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.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, d1 brand name, d4 catalog#, d4 serial#, d4 unique identifier (udi)#, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code ¿ explain, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 29th february 2024, getinge became aware of an issue with one of our mobile tables - 113322f5 - alphamaxx surgical table w/auto drive.As it was stated, the table was stuck in the uppermost position during procedure and would not move.According to the customer allegation, the position put the patient at risk of falling off table.No additional details regarding the performed procedure and patient positioning have been received to date.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the inability to move the table resulting in delay or interruption in life-saving surgery and potentially creating risk of patient falling from the table, was to reoccur.Corrected b5 describe event or problem: on 29th february 2024, getinge became aware of an issue with one of our mobile tables - 113322f5 - alphamaxx surgical table w/auto drive.As it was stated, the table was stuck in the uppermost position during procedure and would not move.According to the customer allegation, the position put the patient at risk of falling off table.No additional details regarding the performed procedure and patient positioning have been received.The incident was initially assessed as reportable based on the potential for serious injury if the situation, namely the inability to move the table resulting in delay or interruption in life-saving surgery and potentially creating risk of patient falling from the table, was to reoccur.Recently, the record has been reevaluated.According to the performed review, the information regarding the initial occurrence of the malfunction on this device was received in december 2023.Based on additional input from getinge employee it was possible to determine that the customer did not accept the quotation and no repair was performed after the issue had been detected.As the customer deliberately used a defective product, it has been concluded that the scenario described in the record is considered as non-reportable.Previous d1 brand name: alphamaxx surgical table w/auto drive.Corrected d1 brand name: alphamaxx mobile operating table.Previous d4 catalog#: 113322f5.Corrected d4 catalog #: n/a.Previous d4 serial#: (b)(6).Corrected d4 serial#: (b)(6).Previous d4 unique identifier (udi)#: n/a.Corrected d4 unique identifier (udi)#: (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device evaluation anticipated, but not yet begun.Corrected h3c if other provide code - explain: n/a.Previous h4 device manufacture date: 04/01/2015.Corrected h4 device manufacture date: 04/21/2015.
Event or Problem Description
On 29th february 2024, getinge became aware of an issue with one of our mobile tables - 113322f5 - alphamaxx surgical table w/auto drive.As it was stated, the table was stuck in the uppermost position during procedure and would not move.According to the customer allegation, the position put the patient at risk of falling off table.No additional details regarding the performed procedure and patient positioning have been received.The incident was initially assessed as reportable based on the potential for serious injury if the situation, namely the inability to move the table resulting in delay or interruption in life-saving surgery and potentially creating risk of patient falling from the table, was to reoccur.Recently, the record has been reevaluated.According to the performed review, the information regarding the initial occurrence of the malfunction on this device was received in december 2023.Based on additional input from getinge employee it was possible to determine that the customer did not accept the quotation and no repair was performed after the issue had been detected.As the customer deliberately used a defective product, it has been concluded that the scenario described in the record is considered as non-reportable.

• Brand Name: ALPHAMAXX MOBILE OPERATING TABLE
• Common Device Name: 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: 18864226
• Report Number: 8010652-2024-00038
• Device Sequence Number: 15543796
• Product Code: FQO
• UDI-Device Identifier: 04046768040052
• UDI-Public: (01)04046768040052
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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
• Device Model Number: 113322F5
• Device Catalogue Number: 113322F5
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown