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

Model Number	720001B0
Medical Device Problem Codes	Use of Device Problem (1670); Device Fell (4014)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site name: (b)(6).Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an incident with one of our mobile tables ¿ 720001b0 - meera eu without auto drive.As it was stated, during surgery, the table's base fell on the doctor's foot which resulted in a fracture.According to the provided information, the table was in the reverse trendelenburg and most likely the table got caught on the object that was placed underneath which consequently resulted in lifting the base of meera table.When the movement of the table was initiated, the object which supported the table's weight moved and the base of the table dropped on the user's foot.The staff released the doctor's foot and he was taken to the emergency room for treatment.Additional information regarding user's outcome has been requested.No patient harm has been reported.We decided to report the issue due to the serious injury of the user.
Additional Manufacturer Narrative
On 7th july 2023, getinge became aware of an incident with one of our mobile tables ¿ 720001b0 - meera eu without auto drive.As it was stated, during a surgery, the table's base fell on the doctor's foot what resulted in a fracture.According to the provided information, the table was in the reverse trendelenburg and most likely the table got caught on the object that was placed underneath.It consequently resulted in lifting the base of the meera table.By the time the movement of the table was initiated, the object that supported the table's weight moved and the base of the table dropped.The staff released the doctor's foot.The analgesics were administered to the affected user and he was taken to the emergency room for treatment.No further details regarding user's outcome were received.We decided to report the issue due to serious injury of the user.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As no malfunction that could contribute to the event was found, it was considered 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 of the users when this kind of event occurred.Comparing the number of the devices involved in the adverse event to the number of the meera mobile tables placed on the market we can conclude the failure ratio is 0,08% for the issue of table falling on user's foot.The affected getinge device has been evaluated by the getinge technician.The inspection of the table revealed no damages or oil leaks.The technician tested the movements of the table with the use of the wired remote control and a non-critical alert message ¿code 81d03¿ was displayed which indicates a failure in the pressure switch function to lock/unlock the wheels.No movement fault was found and there was no leaking piston or damaged hydraulic hose.The technician emphasized that everything indicated that something was under the table near the foot side and when the table was moved, the object supported the table's foot side and raised the base of the table in an unnoticed way.In consequence, when the movement of the table was performed, the object that was below moved and the base of the table came down on top of the doctor's foot.After that, the hospital staff lifted the table to remove the doctor¿s foot.The technician found the malfunction of the plastic covers (part number 37103329) and fixation clip (part number 86016543), however, it was confirmed that those malfunctions did not lead or contribute to the event but were caused due to its occurrence the pump and the wheel locking key were manually activated by the central column panel and the mechanism returned to normal.The technician checked locking and unlocking the wheels by the remote control without presenting a failure and tested all the table¿s movements.No malfunctions were found.The technician tried to recreate the event with the handle of a rubber hammer to understand how the surgeon's foot got trapped under the table.It was noticed that when the table was unlocked, the handle of the hammer could enter under the base of the table.On the opposite, when the table was locked the technician could not enter the handle of the hammer as the base was very close to the ground.Therefore, it was assumed that, by the time of the event occurrence, the table was not locked.After that, the table was opened and checked.No oil leakage or faults with the hoses, cylinders and other parts of the column were found.The table was tested with a weight of +/- 100 kg, in motion and the table showed no failures or errors.In the user manual (ifu 7200.01 en 13 2023-07-20, page 27) the user is also warned that when setting down the or table, there is a risk of crushing and shearing to the feet or objects.Before putting down the or table, the user needs to be sure there are no objects located under the or table base.When lowering the or table, the user needs to keep a sufficient distance to the or table base.The user is also warned to park the mobile operating table on level ground and secure it with the [lock] function before each application and after each movement (ifu 7200.01 en 13 2023-07-20, page 27).In summary and as a result of the root cause evaluation, it can be concluded that the root cause of the reported issue, namely the base of the table dropping during surgery leading to the serious injury of the user, was user error as it is probable that the user disregarded the safety notes from the instruction for use.In our evaluation the information we currently hold does not warrant any 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 additional information that has been received.Previous b5 describe event or problem: on 7th july 2023 getinge became aware of an incident with one of our mobile tables ¿ 720001b0 - meera eu without auto drive.As it was stated, during surgery, the table's base fell on the doctor's foot which resulted in a fracture.According to the provided information, the table was in the reverse trendelenburg and most likely the table got caught on the object that was placed underneath which consequently resulted in lifting the base of meera table.When the movement of the table was initiated, the object which supported the table's weight moved and the base of the table dropped on the user's foot.The staff released the doctor's foot and he was taken to the emergency room for treatment.Additional information regarding user's outcome has been requested.No patient harm has been reported.We decided to report the issue due to the serious injury of the user.Corrected b5 describe event or problem: on 7th july 2023, getinge became aware of an incident with one of our mobile tables ¿ 720001b0 - meera eu without auto drive.As it was stated, during a surgery, the table's base fell on the doctor's foot what resulted in a fracture.According to the provided information, the table was in the reverse trendelenburg and most likely the table got caught on the object that was placed underneath.It consequently resulted in lifting the base of the meera table.By the time the movement of the table was initiated, the object that supported the table's weight moved and the base of the table dropped.The staff released the doctor's foot.The analgesics were administered to the affected user and he was taken to the emergency room for treatment.No further details regarding user's outcome were received.We decided to report the issue due to serious injury of the user.
Event or Problem Description
On 7th july 2023, getinge became aware of an incident with one of our mobile tables ¿ 720001b0 - meera eu without auto drive.As it was stated, during a surgery, the table's base fell on the doctor's foot what resulted in a fracture.According to the provided information, the table was in the reverse trendelenburg and most likely the table got caught on the object that was placed underneath.It consequently resulted in lifting the base of the meera table.By the time the movement of the table was initiated, the object that supported the table's weight moved and the base of the table dropped.The staff released the doctor's foot.The analgesics were administered to the affected user and he was taken to the emergency room for treatment.No further details regarding user's outcome were received.We decided to report the issue due to serious injury of the user.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
E1h event site postal code: (b)(6).The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.The correction of d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, 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 d1 brand name: meera eu without auto drive.Corrected d1 brand name: meera mobile operating table.Previous d4 catalog #: 720001b0.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4).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.
Additional Manufacturer Narrative
The correction of e1 initial reporter, e1 event site address, e1 event site telephone, e1 event site email fields deems required.This is based on the internal evaluation.Previous e1 initial reporter: (b)(6).Corrected e1 initial reporter: (b)(6).Previous e1 event site address: (b)(6).Corrected e1 event site address: (b)(6).Previous e1 event site telephone: (b)(6).Corrected e1 event site telephone: (b)(6).Previous e1 event site email: (b)(6).Corrected e1event site email: (b)(6).Full e1 event site address: (b)(6).Full e1 initial reporter: (b)(6).
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: MEERA 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: 17297149
• Report Number: 8010652-2023-00054
• Device Sequence Number: 17072612
• Product Code: FQO
• UDI-Device Identifier: 04046768124332
• UDI-Public: (01)04046768124332
• 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,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 720001B0
• Device Catalogue Number: 720001B0
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 11/12/2024; 11/26/2024
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 01/11/2024; 11/13/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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