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

Model Number	710001B0
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
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).H3 other text: device not returned to manufacturer.
Event or Problem Description
On 2nd october 2023 getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the base of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.Additional details of the event and user's outcome were requested, however, no information has been received to date.It was confirmed that the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the base of the table, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the column of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.It was confirmed that the surgery was not delayed and the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the table¿s column, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus were also directly involved with the reported incident.As no malfunction connected to the reportable event occurrence was found, it was considered that the getinge device was up to its specification.A review of the received customer product complaints revealed that in the past there was no serious injury to the patient or user when this particular issue occurred.Comparing the number of complained devices to the number of investigated meera operating tables on the market we can conclude the failure ratio is (b)(4) for the issue investigated herein.The issue investigated herein is a single and isolated case.According to the customer, the doctor was on the right side of the device.The technician has stated that this operating table model does not perform any movement in the base that makes the occursion claimed by the customer possible, as the locking system has a mechanical lock located on the base on the head side.The ssu concluded that it is probable by the time of the event occurrence was with his foot on the top of the operating table¿s base and leaning against the column.When moving it down, one of the covers pressed the side of the doctor¿s foot, as it did not cause any major injury.In the instruction for use (ifu 7100.01 rev 2, page 25), the user is warned that when adjusting, moving or storing the or table, the staff, the patient and the accessories are exposed to pinching and shearing hazards, particularly in the area around the joints at the head rest, back and leg plates.The user shall always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.In the ifu (ifu 7100.01 rev 2, page 27), the user is also warned that any objects left on the base of the or table will damage the casing as it moves.The user shall not put any objects on the or table base.It is likely that the user utilized the operating table disregarding safety notes and suggestions from the user manual.In summary and as a result of the performed root cause evaluation, it was concluded that based on available information it can be suspected that the most probable root cause of the reported issue, namely the user's foot being pressed by the table¿s column, is related to the user error.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.E1h event site postal code: (b)(6).The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous b1 adverse event / product problem: adverse event & product problem corrected b1 adverse event / product problem: adverse event.Previous d1 brand name: meera st eu without auto drive corrected d1 brand name: meera st mobile operating table.Previous d4 catalog #: 710001b0.Corrected d4 catalog #: n/a.Previous b5 describe event or problem: on 2nd october 2023 getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the base of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.Additional details of the event and user's outcome were requested, however, no information has been received to date.It was confirmed that the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the base of the table, was to reoccur.Corrected b5 describe event or problem: on 2nd october 2023 getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the column of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.It was confirmed that the surgery was not delayed and the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the table¿s column, was to reoccur.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.Previous h6 medical device ¿ problem code: insufficient information|||3190.Corrected h6 medical device ¿ problem code: use of device problem|||1670.
Event or Problem Description
On 2nd october 2023 getinge became aware of an issue with one of our mobile tables - 710001b0 - meera st eu without auto drive.As it was stated, the following course of events occurred.The doctor was on the right side of the device.The table was in the trendelenburg position titled to the right.After repositioning the table into zero position by performing the downward movement, the doctor's foot was pressed laterally by the column of the table leading to skin injury of the user.According to the provided information, the incident did not result in any major injury.It was confirmed that the surgery was not delayed and the patient was not harmed in this event.We decided to report the issue based on the potential for serious injury if the situation, namely the user's foot being pressed by the table¿s column, was to reoccur.

• Brand Name: MEERA ST 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: 17903383
• Report Number: 8010652-2023-00098
• Device Sequence Number: 15428191
• Product Code: FQO
• UDI-Device Identifier: 04046768136298
• UDI-Public: (01)04046768136298(11)191106
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 710001B0
• Device Catalogue Number: 710001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown