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

Model Number 720001B0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 16th june, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive and 141901jc extension device.At the time of event, 141901jc extension device followed by amis extension (medacta) were attached to 720001b0 meera eu without auto drive.As it was stated, the event occurred at the end of surgery during preparation for transfer of the intubated patient in the pre-awakening phase.The staff was trying to detach amis extension to make a room for a transporter.This action led to the detachment of amis extension as well as 141901jc extension device, which resulted in patient falling down.The patient was examined and an x-ray was performed.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of reoccurance.

Manufacturer Narrative

On 16th june, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive and 141901jc extension device.At the time of event, 141901jc extension device followed by amis extension (medacta) were attached to 720001b0 meera eu without auto drive.As it was stated, the event occurred at the end of surgery during preparation for transfer of the intubated patient in the pre-awakening phase.According to the report prepared by the customer after the incident, the position of table top was changed from trendelenburg to horizontal position which reportedly led to a collision of the table top with the image amplifier that was placed under the table.This collision may have caused a lever arm to have partially dislodged the 141901jc extension device, but the amis extension probably prevented its fall.When the or staff was trying to detach amis extension to make a room for a transporter, both extension devices detached from the table.Consequently, the patient started to fall from the table.Fortunately, the patient was caught by the staff before hitting the floor.The patient was examined and an x-ray was performed.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of reoccurrence.According to all available information, there was no malfunction with the mobile table itself.Based on the information provided by the getinge technician and the report prepared by the or staff after the incident, the issue occurred due to the user error.It was established that when the event occurred, the mobile table did meet its specification.Provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred the table was directly involved with the reported incident.According to the report prepared after the event by the or staff, the incident was caused by the or staff manipulation and collision of the table with the patient on it.In the instruction for use for the extension device, the user is informed that mounting any other extension adapters to the product is not allowed.Based on the information provided by the product manager, the suitable of the amis extension device and getinge products was never tested and the combination of these products was not released to the use.In the instruction for use for the meera mobile table, the user is warned that accessories not approved by maquet for this product and accessories from other manufacturers may cause injuries.The user is also warned that the patient may be endangered as a result of incorrect use and to make sure that there are no objects located under the or table base.The root cause for the reported issue is considered as being most likely a user error, since it would appear that the user manipulated the table with patient on it and disregarded safety notes from user manuals.A review of received customer product complaints related to investigated issues revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices (1) to the number of units placed on the market (approx.(b)(4)) we can conclude the failure ratio is (b)(4) and that this is single and isolated case for situations where the patient started to fell due to manipulation and collision of the table.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.

Event Description

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

Event Description

On 16th june, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive and 141901jc extension device.At the time of event, 141901jc extension device followed by amis extension (medacta) were attached to 720001b0 meera eu without auto drive.As it was stated, the event occurred at the end of surgery during preparation for transfer of the intubated patient in the pre-awakening phase.The position of table top was changed from trendelenburg to horizontal which led to collision of the table top with the image amplifier that was placed under the table.Subsequently, the staff was trying to detach amis extension to make a room for a transporter.This action led to the detachment of amis extension as well as 141901jc extension device., the patient started to fall from the table.Fortunately, the patient was caught by the staff before hitting the floor.The patient was examined and an x-ray was performed.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of recurrence.

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 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 16th june, 2022 getinge became aware of an issue with one of our mobile tables ¿ 720001b0 meera eu without auto drive and 141901jc extension device.At the time of event, 141901jc extension device followed by amis extension (medacta) were attached to 720001b0 meera eu without auto drive.As it was stated, the event occurred at the end of surgery during preparation for transfer of the intubated patient in the pre-awakening phase.The staff was trying to detach amis extension to make a room for a transporter.This action led to the detachment of amis extension as well as 141901jc extension device, which resulted in patient falling down.The patient was examined and an x-ray was performed.There was no injury of the patient or staff reported, however, we decided to report the issue based on potential that similar event could lead to serious injury in case of reoccurance.

• 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: 14840970
• MDR Text Key: 302922133
• Report Number: 8010652-2022-00010
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 141901JC EXTENSION DEVICE