MAUDE Adverse Event Report: MAQUET GMBH MEERA EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B2

Device Problem Positioning Problem (3009)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

On 17th march 2023 getinge became aware of an issue with one of our mobile tables ¿ 710001b2 - meera st eu with auto drive.Following the baby delivery during emergency caesarean section, the staff tried to raise operating table for a better working position.As it was stated, the table could not be operated with remote control nor override panel, all movements were blocked and error message 0x20604 was displayed.The surgery was completed on the operating table in the low position with minor delay.There was no injury of the patient reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the table not responding to remote control and override panel during surgery leading to inability to position table as required and delay in surgery resulting in prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 720001b2 - meera eu with auto drive.Following the baby delivery during emergency caesarean section, the staff tried to raise operating table for a better working position.As it was stated, the table could not be operated with remote control or override panel, all movements were blocked and error message 0x20604 was displayed.The surgery was completed on the operating table in the low position with minor delay.There was no injury of the patient reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the table not responding to remote control and override panel during surgery leading to inability to position table as required and delay in surgery resulting in prolonged anesthesia time, was to reoccur.The affected getinge device has been evaluated by the company¿s service technician.The technician has confirmed the malfunction of the operating table.He has noticed errors 81d03 and 8533f.The table was in low position.The technician disconnected the two battery cables and the third connection on the charger board.After reconnecting these three, everything worked properly.The device was tested and released to usage.The technician has reached out to technical support at manufacturing site.Based on the provided error log, the technical support assessed that error 0x20604 was not related to the hand control but to the table.According to the technical support team, this kind of error might occur for example when a move function on the table is pressed and the pump is running, but the valves are not working or if a plug of the pump is not fully attached to the main board, causing pump not running, but valve working.The error pattern described by the technical support could not be confirmed by the ssu at customer¿s site.The subject matter experts (smes) at the manufacturing site were contacted for the root cause assessment.The sme suspected batteries or charger board defect.The error pattern suspected by the sme could not be confirmed as the issue was not reproducible.If batteries were defective, they would malfunction permanently and error 8533f would point on communication issue leading to control unit to not reach the charger board.However no further problem with both control unit and charger board were noted.To conclude, according to the sme as the claimed issue could not be reproduced the root cause for the issue occurrence remains impossible do define.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 malfunction of the operating table was found, it was considered that the getinge device was not up to the specification.The issue investigated herein is a single and isolated case.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 version or model # and d4 catalog # fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 17th march 2023 getinge became aware of an issue with one of our mobile tables ¿ 710001b2 - meera st eu with auto drive.Following the baby delivery during emergency caesarean section, the staff tried to raise operating table for a better working position.As it was stated, the table could not be operated with remote control nor override panel, all movements were blocked and error message 0x20604 was displayed.The surgery was completed on the operating table in the low position with minor delay.There was no injury of the patient reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the table not responding to remote control and override panel during surgery leading to inability to position table as required and delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 17th march 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b2 - meera eu with auto drive.Following the baby delivery during emergency caesarean section, the staff tried to raise operating table for a better working position.As it was stated, the table could not be operated with remote control or override panel, all movements were blocked and error message 0x20604 was displayed.The surgery was completed on the operating table in the low position with minor delay.There was no injury of the patient reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the table not responding to remote control and override panel during surgery leading to inability to position table as required and delay in surgery resulting in prolonged anesthesia time, was to reoccur.Previous d1 brand name: meera st eu with auto drive corrected d1 brand name: meera eu with auto drive previous d4 version or model # 710001b2 corrected d4 version or model # 720001b2 previous d4 catalog # 710001b2 corrected d4 catalog # 720001b2.

Event Description

On 17th march 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b2 - meera eu with auto drive.Following the baby delivery during emergency caesarean section, the staff tried to raise operating table for a better working position.As it was stated, the table could not be operated with remote control or override panel, all movements were blocked and error message 0x20604 was displayed.The surgery was completed on the operating table in the low position with minor delay.There was no injury of the patient reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the table not responding to remote control and override panel during surgery leading to inability to position table as required and delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: MEERA EU WITH AUTO DRIVE
• 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: 16608197
• MDR Text Key: 312213299
• Report Number: 8010652-2023-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female