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

Model Number 720001B0

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Localized Skin Lesion (4542)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 6th june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after the high-frequency surgery (possibly a child birth) performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.Up to the day of the report, there were no further findings regarding circumstances of the event, incident severity and consequences for the patient.There was no serious injury reported, however, we decided to report the issue based on the potential for serious injury if the situation was to reoccur.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b3 date of event, b5 describe event or problem, e1c event site address, e1e event site city, e1h event site postal code, h1 type of reportable event, h6 health effect ¿ clinical code and h6 health effect ¿ impact codes fields deems required.This is based on the additional information that has been received.Previous b3 date of event: 06/06/2023.Corrected b3 date of event: 05/18/2023.Previous b5 describe event or problem: on 6th june 2023, getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after the high-frequency surgery (possibly a child birth) performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.Up to the day of the report, there were no further findings regarding circumstances of the event, incident severity and consequences for the patient.There was no serious injury reported, however, we decided to report the issue based on the potential for serious injury if the situation was to reoccur.Corrected b5 describe event or problem: on 6th june 2023, getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after the high-frequency surgery (possibly a child birth) performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.According to the provided information, the table was covered with paper sheet at the time of incident.Up to the day of the initial report, there were no further findings regarding circumstances of the event, incident severity and consequences for the patient.On 4th october 2023, additional details regarding patient's injury have been received.As it was stated, skin lesion with blistering on the patient's coccyx measuring 50 cm2 was identified and assessed as serious injury.Previous e1c event site address: (b)(6).Previous h1 type of reportable event: malfunction.Corrected h1 type of reportable event: serious injury.Previous h6 health effect ¿ clinical code: skin and subcutaneous tissue|burn(s)||1757.Corrected h6 health effect ¿ clinical code: skin and subcutaneous tissue|localized skin lesion||4542.Previous h6 health effect ¿ impact codes: minor injury/ illness / impairment|||4613.Corrected h6 health effect ¿ impact codes: prolonged episode of care|||4620, serious injury/ illness/ impairment|||4614.

Event Description

On 6th june 2023, getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after the high-frequency surgery (possibly a child birth) performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.According to the provided information, the table was covered with paper sheet at the time of incident.Up to the day of the initial report, there were no further findings regarding circumstances of the event, incident severity and consequences for the patient.On 4th october 2023, additional details regarding patient's injury were received.As it was stated, skin lesion with blistering on the patient's coccyx measuring 50 cm2 was identified and assessed as serious injury.

Event Description

On 6th june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after cesarean section with the use of the high frequency performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.On 4th october, we became aware of the report prepared by erbe, which stated that the patient suffered skin lesions on the buttocks described as blisters with a size of 50 cm2.The clinical expert has assessed the harms as a combination of chemical burn and decubitus.The patient had consultative co-treatment with wound care performed.Primarily, the complaint was reported based on the potential for serious injury, if the investigated event was to reoccur.According to the newly obtained information, we decided to report the issue due to the serious injury of the patient.

Manufacturer Narrative

On 6th june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after cesarean section with the use of the high frequency performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.On 4th october, we became aware of the report prepared by erbe, which stated that the patient suffered skin lesions on the buttocks described as blisters with a size of 50 cm2.The clinical expert has assessed the harms as a combination of chemical burn and decubitus.The patient had consultative co-treatment with wound care performed.Primarily, the complaint was reported based on the potential for serious injury, if the investigated event was to reoccur.According to the newly obtained information, we decided to report the issue due to the serious injury of the patient.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was directly involved with the reported incident.As no malfunction with the device was reported, it has been assessed that the getinge device was up to the specification.A review of the received customer product complaints revealed that the issues led to serious injuries to the users.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the issue investigated herein is 0,02% as there was one similar reportable customer product complaint related to the investigated issue.The affected getinge device has not been evaluated by the company¿s service technician.The customer does not have a maintenance contract with getinge and there was no service order submitted by the customer.The clinical expert assessed that it seemed that the (two) burns were coming from too wet patient¿s disinfection, which means that the skin disinfectant was coming below the patient and the patient was laying constantly on a wet surface what has been caused by the user¿s fault.In the report provided by erbe, the manufacturer of the electrosurgical device, it has been assessed that the skin lesion was not caused by their device.It has been established that a major skin lesion in bipolar electrosurgical application by electrosurgery is almost impossible.The report concludes the connection between the use of this medical device and the incident based on the available information is not understood.According to the report, it is very likely that the harm can be classified as pressure necrosis in combination with moisture (e.G.Sweat/blood/urine/disinfectant/amniotic fluid).In addition, an allergic skin reaction to the disinfectant/the liquids used or an etching may be the cause of the skin lesion.As additional reinforcing factors, there are also the pressure of the patient¿s own weight and shear forces, which occur during positioning.Getinge clinical expert established that the harm could be a mix of chemical burn and decubitus, and as erbe mentioned, may be also an allergic reaction to the disinfection.He stated that the problem is related to a workflow or materials used by the hospital.In the instructions for use (ifu 7200.01 en 11, page 25), the user is warned that the use of high-frequency devices, defibrillators and defibrillator monitors, while the patient is resting on wet drapes exposes them to burn risks.The user should never use damp or wet surgical drapes.In the ifu (ifu 7200.01 en 11, page 25), the user is warned that improper patient positioning may cause health damage (e.G.Decubitus).The user shall position the patient correctly and keep them under constant observation.It is likely that the user utilized the operating table disregarding safety notes and suggestions from the user manual.In summary, based on all available information it has been established that the root cause for the issue investigated herein, was most likely related to the user error.We believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.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 field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 6th june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after the high-frequency surgery (possibly a child birth) performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.According to the provided information, the table was covered with paper sheet at the time of incident.Up to the day of the initial report, there were no further findings regarding circumstances of the event, incident severity and consequences for the patient.On 4th october 2023, additional details regarding patient's injury were received.As it was stated, skin lesion with blistering on the patient's coccyx measuring 50 cm2 was identified and assessed as serious injury.Corrected b5 describe event or problem: on 6th june 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, after cesarean section with the use of the high frequency performed with erbe vio 300 / 50 w bipolar device, it has been noticed that the patient suffered burns in the buttock area.On 4th october, we became aware of the report prepared by erbe, which stated that the patient suffered skin lesions on the buttocks described as blisters with a size of 50 cm2.The clinical expert has assessed the harms as a combination of chemical burn and decubitus.The patient had consultative co-treatment with wound care performed.Primarily, the complaint was reported based on the potential for serious injury, if the investigated event was to reoccur.According to the newly obtained information, we decided to report the issue due to the serious injury of the patient.

• 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: 17124740
• MDR Text Key: 317460192
• Report Number: 8010652-2023-00046
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ERBE VIO 300 / 50 W BIPOLAR DEVICE.
• Patient Outcome(s): Other
• Patient Age: 34 YR