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

Model Number	770001B2
Medical Device Problem Codes	Computer Software Problem (1112); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6) hospital, e1h event site postal code: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 770001b2 - corin w autodrive, sfc, eu.As it was stated, all functions stopped working and the table could not be levelled via hand control or override panel during surgery.The table was in normal orientation with full longitudinal shift to the foot site, 20 degrees of trendelenburg and 3 degrees of right lateral tilt applied and column at the lowest permitted height for this table top position.Following service visit on site, it was confirmed that no movement occurs when the ¿0¿ or ¿left lateral tilt¿ buttons on the remote control or ¿left lateral tilt¿ and ¿power¿ buttons on the override panel are being pressed.The warning lights went amber and there was audible tone.The table was fully charged and hand control ir was not showing low battery.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient during procedure, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables - 770001b2 - corin w autodrive, sfc, eu.As it was stated, all functions stopped working and the table could not be levelled via hand control or override panel during surgery.The table was in normal orientation with a full longitudinal shift to the foot site, 20 degrees of trendelenburg and 3 degrees of right lateral tilt applied and column at the lowest permitted height for this tabletop position.The operation was completed on the affected table with a delay of 5-10 minutes.Following the service visit on site, it was confirmed that no movement occurs when the ¿0¿ button was being pressed.The warning lights went amber and there was an audible tone.The table was fully charged and the hand control ir was not showing a low battery.Initially, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient during the procedure, was to reoccur.Recently, the case has been reevaluated based on the research and development's statement, which confirmed that the error is reproducible and the '0' function does not work in the described situation, however, the position can always be changed by triggering reverse trend and/or lift up functions.Therefore, the scenario described in the record is considered as non-reportable.It was established that the device failed to meet the manufacturer's specification due to a software issue.The device was being used for patient treatment when the malfunction occurred.The request to update the software has been raised.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, h6 medical device ¿ problem code, h6 component codes and h6 health effect ¿ impact codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: getinge became aware of an issue with one of our mobile tables - 770001b2 - corin w autodrive, sfc, eu.As it was stated, all functions stopped working and the table could not be levelled via hand control or override panel during surgery.The table was in normal orientation with full longitudinal shift to the foot site, 20 degrees of trendelenburg and 3 degrees of right lateral tilt applied and column at the lowest permitted height for this tabletop position.Following service visit on site, it was confirmed that no movement occurs when the ¿0¿ or ¿left lateral tilt¿ buttons on the remote control or ¿left lateral tilt¿ and ¿power¿ buttons on the override panel are being pressed.The warning lights went amber and there was audible tone.The table was fully charged and hand control ir was not showing low battery.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient during procedure, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our mobile tables - 770001b2 - corin w autodrive, sfc, eu.As it was stated, all functions stopped working and the table could not be levelled via hand control or override panel during surgery.The table was in normal orientation with a full longitudinal shift to the foot site, 20 degrees of trendelenburg and 3 degrees of right lateral tilt applied and column at the lowest permitted height for this tabletop position.The operation was completed on the affected table with a delay of 5-10 minutes.Following the service visit on site, it was confirmed that no movement occurs when the ¿0¿ button was being pressed.The warning lights went amber and there was an audible tone.The table was fully charged and the hand control ir was not showing a low battery.Initially, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient during the procedure, was to reoccur.Recently, the case has been reevaluated based on the research and development's statement, which confirmed that the error is reproducible and the '0' function does not work in the described situation, however, the position can always be changed by triggering reverse trend and/or lift up functions.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: activation, positioning or separation problem|positioning failure|1158.Corrected h6 medical device ¿ problem code: computer software problem|||1112.Previous h6 component codes: others|insufficient information||4776.Corrected h6 component codes: electrical and magnetic|computer software||4707.Previous h6 health effect ¿ impact codes: no health consequences or impact|||2199.Corrected h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632.
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 770001b2 - corin w autodrive, sfc, eu.As it was stated, all functions stopped working and the table could not be levelled via hand control or override panel during surgery.The table was in normal orientation with a full longitudinal shift to the foot site, 20 degrees of trendelenburg and 3 degrees of right lateral tilt applied and column at the lowest permitted height for this table top position.The operation was completed on the affected table with a delay of 5-10 minutes.Following the service visit on site, it was confirmed that no movement occurs when the ¿0¿ button was being pressed.The warning lights went amber and there was an audible tone.The table was fully charged and the hand control ir was not showing a low battery.Initially, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient during the procedure, was to reoccur.Recently, the case has been reevaluated based on the research and development's statement, which confirmed that the error is reproducible and the '0' function does not work in the described situation, however, the position can always be changed by triggering reverse trend and/or lift up functions.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: CORIN 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: 20851507
• Report Number: 8010652-2024-0000096
• Device Sequence Number: 17126060
• Product Code: FQO
• UDI-Device Identifier: 04046768145207
• UDI-Public: (01)04046768145207(11)240503
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/05/2024

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: 770001B2
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown