MAUDE Adverse Event Report: MAQUET GMBH MEERA EU WITHOUT AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B0

Device Problems Circuit Failure (1089); Positioning Failure (1158); Moisture Damage (1405)

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.E1 event site name: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 23rd june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table could not be operated via the remote control or override panel during the surgery due to water ingress.The table was stuck in beach chair position and was very low.The patient was removed from the table with difficulty and the surgery continued on another table.There was no injury 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 leading to inability to position table as required, was to reoccur.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table could not be operated via the remote control or override panel during the surgery due to water ingress.The table was stuck in beach chair position and was very low.The patient was removed from the table with difficulty and the surgery continued on another table.There was no injury 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 leading to inability to position table as required, was to reoccur.The affected getinge device has been evaluated by the getinge service technician.The technician has confirmed the malfunction of the operating table.The technician has replaced charging unit and circlips.As the preventive maintenance has never been performed on the device oil was also refitted.The operating table was released to usage.During the repair, the technician has noticed internal water.According to the general device specification (ifu 7200.01 en 09, page 114), the device has an ip x4 spray water protection against ingress of liquids.In the instructions for use (ifu 7200.01 en 09, page 101), the user is warned to ensure that no liquids can penetrate any live parts.The user is also warned that improper cleaning and disinfection can cause property damage (ifu 7200.01 en 09, page 102).The user is instructed to use only as much detergent and disinfectant as is required.On the same page the user can also find a safety note stating that they should perform visual and functional inspections after each cleaning and disinfection process.The user is informed (ifu 7200.01 en 09, page 104), not to splash detergents directly into gasps or openings.In ¿maintenance¿ chapter user can find a recommendation to have visual and functional inspections performed by a trained person prior to each use.According to the information gathered, the customer does not have a maintenance contract with getinge.The operating table has never undergone preventive maintenance.In the ifu (ifu 7200.01 en 09, page 112), the user is instructed that maintenance must be performed every 2 years and, as of the 5th year, every year.The subject matter expert at manufacturing site confirmed that based on all gathered information the investigated issue was caused by the user.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.Based on all available information the most likely root cause for the issue investigated herein is user error.In summary, this complaint is the second one registered for meera operating table where operating table was inoperative via the remote control or override panel during the surgery.(b)(4).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.

Manufacturer Narrative

The correction of b5 describe event or problem field deems required due to the update of awareness date.This is based on the internal evaluation.Previous b5 describe event or problem: on 23rd june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, the table could not be operated via the remote control or override panel during the surgery due to water ingress.The table was stuck in beach chair position and was very low.The patient was removed from the table with difficulty and the surgery continued on another table.There was no injury 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 leading to inability to position table as required, was to reoccur.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields also deems required.This is based on the internal evaluation.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 not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.

Event Description

On 22nd june 2023 getinge became aware of an issue with one of our mobile tables ¿ (b)(6) meera eu without auto drive.As it was stated, the table could not be operated via the remote control or override panel during the surgery due to water ingress.The table was stuck in beach chair position and was very low.The patient was removed from the table with difficulty and the surgery continued on another table.There was no injury 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 leading to inability to position table as required, was to reoccur.

• Brand Name: MEERA EU WITHOUT 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: 17224875
• MDR Text Key: 318107633
• Report Number: 8010652-2023-00052
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1