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

Model Number 720001B0

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

The following was reported to us.Mobile table 720001b0 meera eu without auto drive (maquet) was used with mayfield ultra 360 head holder (owa tsusho), which was attached to head plate and supported on the floor.After the surgery base of the table was lifted and part of the table's weight rested on the attached accessory.Nurse tried to remove the accessory.As it turned out her foot was in the gap between floor and operating room table.Therefore, when the accessory was pulled out, the table came down on her foot, resulting in fractured bone.

Manufacturer Narrative

Getinge became aware of an issue with 720001b0 meera eu without auto drive.It was stated that the operating table was used with mayfield ultra 360 head holder (manufactured by owa tsusho), which was attached to the head plate and supported on the floor.After the surgery base of the table was lifted and part of the table's weight rested on the attached accessory.The nurse tried to remove the accessory.As it turned out her foot was in the gap between the floor and or table.Therefore, when the accessory was pulled out, the table came down on her foot, resulting in a fractured bone.Based on information provided by the getinge technician, there was no malfunction with the mobile table itself, however the performed investigation revealed that the mayfield accessory was installed incorrectly.It was established that when the event occurred, the meera operating table did meet its specification and it was directly involved with the reported incident.The provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, 720001b0 meera eu without auto drive was directly involved with the reported incident.The reported issue was caused during the use of the meera operating table with the attached mayfield accessory, which is a single and isolated case per our complaint handling database.The ssu stated that the mayfield accessory was attached to the head plate of unknown origin.In the user manual for meera operating table (ifu720001xyen11_03-1_21q162_0119_f) the user is warned that when setting down the or table, there is a risk of crushing and shearing to the feet or objects and that accessories from other manufacturers may cause injuries.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.There was no malfunction with the operating table found by getinge service technician.In this case, the user did not comply with the safety notes contained in the ifu.Due to the fact that the user disregarded the safety notes from the instruction for use, the root cause for this issue is user error.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.The correction of b5 describe event or problem and d3 manufacturer fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: the following was reported to us.Mobile table 720001b0 meera eu without auto drive (maquet) was used with mayfield ultra 360 head holder (owa tsusho), which was attached to head plate and supported on the floor.After the surgery base of the table was lifted and part of the table's weight rested on the attached accessory.Nurse tried to remove the accessory.As it turned out her foot was in the gap between floor and or table.Therefore, when the accessory was pulled out, the table came down on her foot, resulting in fractured bone.Corrected b5 describe event or problem: on 11th may 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, 720001b0 meera eu without auto drive (maquet) was used with mayfield ultra 360 head holder (manufactured by owa tsusho), which was attached to head plate and supported on the floor.After the surgery, base of the table was lifted and part of the table's weight rested on the attached accessory.Nurse tried to remove the accessory.As it turned out, her foot was in the gap between floor and or table.Therefore, when the accessory was pulled out, the table came down on her foot, resulting in fractured bone.We decided to report the issue due to serious injury of a user.Previous d3 manufacturer: holger ullrich.Corrected d3 manufacturer: maquet gmbh h3 other text : device not returned to manufacturer.

Event Description

On 11th may 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive.As it was stated, 720001b0 meera eu without auto drive (maquet) was used with mayfield ultra 360 head holder (manufactured by owa tsusho), which was attached to head plate and supported on the floor.After the surgery, base of the table was lifted and part of the table's weight rested on the attached accessory.Nurse tried to remove the accessory.As it turned out, her foot was in the gap between floor and or table.Therefore, when the accessory was pulled out, the table came down on her foot, resulting in fractured bone.We decided to report the issue due to serious injury of a user.

• Brand Name: MEERA EU WITHOUT AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 14405376
• MDR Text Key: 291721113
• Report Number: 8010652-2022-00006
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAYFIELD ULTRA 360 (OWA TSUSHO)
• Patient Outcome(s): Other
• Patient Sex: Female